Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
Study Details
Study Description
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: Treatment Arm 1 (Stage 1A)
|
Biological: Placebo
Single subcutaneous injection of placebo
|
Experimental: Treatment Arm 2 (Stage 1A)
|
Biological: PF-04856883
Single subcutaneous injection of PF-04856883
Other Names:
|
Experimental: Treatment Arm 3 (Stage 1A)
|
Biological: PF-04856883
Single subcutaneous injection of PF-04856883
Other Names:
|
Experimental: Treatment Arm 4 (Stage 1A)
|
Biological: PF-04856883
Single subcutaneous injection of PF-04856883
Other Names:
|
Placebo Comparator: Treatment Arm 5 (Stage 1B)
|
Biological: Placebo
Single subcutaneous injection of placebo
|
Experimental: Treatment Arm 6 (Stage 1B)
|
Biological: PF-04856883
Single subcutaneous injection of PF-04856883
Other Names:
|
Experimental: Treatment Arm 7 (Stage 1B)
|
Biological: PF-04856883
Single subcutaneous injection of PF-04856883
Other Names:
|
Experimental: Treatment Arm 8 (Stage 1B)
|
Biological: PF-04856883
Single subcutaneous injection of PF-04856883
Other Names:
|
Placebo Comparator: Treatment Arm 9 (Stage 2)
|
Biological: Placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Other Names:
|
Experimental: Treatment Arm 10 (Stage 2)
|
Biological: PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Other Names:
|
Experimental: Treatment Arm 11 (Stage 2)
|
Biological: PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Other Names:
|
Experimental: Treatment Arm 12 (Stage 2)
|
Biological: PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Other Names:
|
Experimental: Treatment Arm 13 (Stage 2)
|
Biological: PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.
- Number of Participants With Clinically Significant Physical Examination Findings [Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50]
Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.
- Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) [Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50]
ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - <480 msec, 480 - <500 msec >=500; absolute change 30 - <60, >=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline.
- Number of Participants With Vital Sign Abnormalities [Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50]
Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (<) 40 beats per minute (bpm) or greater than (>) 120 bpm, standing/supine systolic pulse < 40 bpm or > 140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.
- Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements [Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50]
Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) <0.8*lower limit of the reference range (LLRR); leukocytes <0.6*LLRR or >1.5*ULRR; platelet count <0.5*LLRR or >1.75*upper limit of the reference range (ULRR); total neutrophils (absolute [abs]), lymphocytes (abs) <0.8*LLRR or >1.2*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) >1.2*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin >1.5*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3*ULRR, albumin, total protein <0.8*LLRR or >1.2*ULRR; blood urea nitrogen (BUN), creatinine >1.3*ULRR; glucose (fasting) <0.6*LLRR or >1.5*ULRR; uric acid >1.2* ULRR; sodium <0.95*LLRR or >1.05*ULRR; potassium, chloride, bicarbonate, calcium <0.9*LLRR or >1.1*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =>20/ high-power field (HPF).
Secondary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1]
- Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22]
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1]
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
- Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22]
Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.
- Apparent Clearance (CL/F) of PF-04856883: Stage 1 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1]
It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only.
- Apparent Clearance (CL/F) of PF-04856883: Stage 2 [predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22]
It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification.
- Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1]
- Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2 [predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22]
- Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1]
- Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2 [predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22]
- Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 [Baseline, Day 3 and 8]
Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC
- Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 [Baseline, Day 3, 15, 24, 29 and 50]
Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
- Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 [Baseline, Day 3 and 8]
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
- Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 [Baseline, Day 3, 15, 24, 29 and 50]
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
- Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 [Baseline, Day 3 and 8]
Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
- Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 [Baseline, Day 3, 15, 24, 29 and 50]
Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
- Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 [Baseline, Day 2, 4, 6, 15, 22 and 29]
- Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 [Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43]
- Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 [Baseline, Day 30]
A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured.
- Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 [Baseline, Day 29 and 50]
HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2.
- Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 [Baseline, Day 8, 15 and 29]
- Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 [Baseline, Day 8, 15, 22, 29 and 50]
- Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 [Baseline, Day 8, 15 and 29]
- Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 [Baseline, Day 8, 15, 22, 29 and 50]
- Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 [Day 1 and 29]
- Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 [Day 1, 29 and 50]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
History of Type 2 diabetes and currently being treated with high dose metformin
-
BMI between 22.0 and 40.0 kg/m2
-
HbA1c between 7.0-10.0%
-
Fasting C-peptide >1.21 ng/mL
Exclusion Criteria:
-
History of clinically significant chronic conditions other than Type 2 diabetes not well controlled by either diet or medications
-
Treatment with anti-diabetic therapies other than metformin
-
History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
-
Males or women of childbearing potential
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Profil Institute for Clinical Research, Inc. | Chula Vista | California | United States | 91911 |
2 | Elite Research Institute | Miami | Florida | United States | 33169 |
3 | Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.) | Miramar | Florida | United States | 33025 |
4 | Atlanta Center for Medical Research | Atlanta | Georgia | United States | 30308 |
5 | ICON Clinical Pharmacology, LLC | Omaha | Nebraska | United States | 68154 |
6 | CRI Worldwide, LLC | Philadelphia | Pennsylvania | United States | 19139 |
7 | Healthcare Discoveries LLC d/b/a ICON Development Solutions | San Antonio | Texas | United States | 78209 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- B1111002
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Data for reporting arm Placebo 1a and 1b in stage 1 was planned to be pooled during analysis, as per protocol. Study consisted of two stages: stage 1 and stage 2. Participants were enrolled and randomized for stage 1 and stage 2 separately. |
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 milligram (mg) subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Period Title: Stage 1 | ||||||||||||
STARTED | 15 | 5 | 6 | 6 | 7 | 5 | 8 | 0 | 0 | 0 | 0 | 0 |
Received Treatment | 15 | 5 | 6 | 6 | 7 | 5 | 7 | 0 | 0 | 0 | 0 | 0 |
COMPLETED | 15 | 5 | 5 | 6 | 6 | 5 | 7 | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Period Title: Stage 1 | ||||||||||||
STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 5 | 7 | 7 | 6 |
Received Treatment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 5 | 7 | 7 | 6 |
COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 5 | 7 | 6 | 6 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | Total |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Total of all reporting groups |
Overall Participants | 15 | 5 | 6 | 6 | 7 | 5 | 8 | 7 | 5 | 7 | 7 | 6 | 84 |
Age, Customized (participants) [Number] | |||||||||||||
<18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Between 18 and 64 years |
15
100%
|
3
60%
|
5
83.3%
|
4
66.7%
|
6
85.7%
|
4
80%
|
6
75%
|
6
85.7%
|
5
100%
|
4
57.1%
|
7
100%
|
6
100%
|
71
84.5%
|
>=65 years |
0
0%
|
2
40%
|
1
16.7%
|
2
33.3%
|
1
14.3%
|
1
20%
|
2
25%
|
1
14.3%
|
0
0%
|
3
42.9%
|
0
0%
|
0
0%
|
13
15.5%
|
Sex: Female, Male (Count of Participants) | |||||||||||||
Female |
15
100%
|
5
100%
|
6
100%
|
6
100%
|
7
100%
|
5
100%
|
8
100%
|
7
100%
|
5
100%
|
7
100%
|
7
100%
|
6
100%
|
84
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
Title | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
---|---|
Description | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state. |
Time Frame | Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all randomized participants who received at least 1 dose of study treatment. |
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 15 | 5 | 6 | 6 | 7 | 5 | 7 | 7 | 5 | 7 | 7 | 6 |
SAE |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
AE |
8
53.3%
|
1
20%
|
0
0%
|
2
33.3%
|
4
57.1%
|
3
60%
|
4
50%
|
4
57.1%
|
5
100%
|
5
71.4%
|
5
71.4%
|
5
83.3%
|
Title | Number of Participants With Clinically Significant Physical Examination Findings |
---|---|
Description | Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems. |
Time Frame | Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all randomized participants who received at least 1 dose of study treatment. |
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36mg Single Dose | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received subcutaneous injection of PF-04856883 4 mg by a 4-week follow up period in Stage 1 | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 15 | 5 | 6 | 6 | 7 | 5 | 7 | 7 | 5 | 7 | 7 | 6 |
Number [participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) |
---|---|
Description | ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - <480 msec, 480 - <500 msec >=500; absolute change 30 - <60, >=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline. |
Time Frame | Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all randomized participants who received at least 1 dose of study treatment. |
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 15 | 5 | 6 | 6 | 7 | 5 | 7 | 7 | 5 | 7 | 7 | 6 |
Maximum PR Interval IFB: >=25 or 50% |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
0
0%
|
0
0%
|
1
14.3%
|
0
0%
|
Maximum QTcB Interval IFB: 30-<60 msec |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
20%
|
1
12.5%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
1
16.7%
|
Maximum QTcF Interval IFB: 30-<60 msec |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Vital Sign Abnormalities |
---|---|
Description | Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (<) 40 beats per minute (bpm) or greater than (>) 120 bpm, standing/supine systolic pulse < 40 bpm or > 140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg. |
Time Frame | Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all randomized participants who received at least 1 dose of study treatment. |
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 15 | 5 | 6 | 6 | 7 | 5 | 7 | 7 | 5 | 7 | 7 | 6 |
Number [participants] |
15
100%
|
5
100%
|
6
100%
|
6
100%
|
7
100%
|
5
100%
|
7
87.5%
|
7
100%
|
5
100%
|
7
100%
|
7
100%
|
6
100%
|
Title | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements |
---|---|
Description | Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) <0.8*lower limit of the reference range (LLRR); leukocytes <0.6*LLRR or >1.5*ULRR; platelet count <0.5*LLRR or >1.75*upper limit of the reference range (ULRR); total neutrophils (absolute [abs]), lymphocytes (abs) <0.8*LLRR or >1.2*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) >1.2*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin >1.5*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3*ULRR, albumin, total protein <0.8*LLRR or >1.2*ULRR; blood urea nitrogen (BUN), creatinine >1.3*ULRR; glucose (fasting) <0.6*LLRR or >1.5*ULRR; uric acid >1.2* ULRR; sodium <0.95*LLRR or >1.05*ULRR; potassium, chloride, bicarbonate, calcium <0.9*LLRR or >1.1*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =>20/ high-power field (HPF). |
Time Frame | Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all randomized participants who received at least 1 dose of study treatment. |
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 15 | 5 | 6 | 6 | 7 | 5 | 7 | 7 | 5 | 7 | 7 | 6 |
Number [participants] |
15
100%
|
5
100%
|
6
100%
|
6
100%
|
7
100%
|
4
80%
|
6
75%
|
7
100%
|
5
100%
|
7
100%
|
7
100%
|
6
100%
|
Title | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1 |
---|---|
Description | |
Time Frame | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacokinetic (PK) parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. |
Arm/Group Title | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg |
---|---|---|---|---|---|---|
Arm/Group Description | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. |
Measure Participants | 5 | 6 | 6 | 7 | 5 | 7 |
Geometric Mean (Geometric Coefficient of Variation) [nanogram per milliliter (ng/mL)] |
181.2
(85)
|
324.7
(61)
|
793.7
(65)
|
1855
(66)
|
1776
(21)
|
2006
(52)
|
Title | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 |
---|---|
Description | |
Time Frame | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 |
Outcome Measure Data
Analysis Population Description |
---|
PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|
Arm/Group Description | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 5 | 7 | 7 | 6 |
Day 1 (n =5, 7, 7, 6) |
1369
(17)
|
1203
(20)
|
1027
(29)
|
1407
(29)
|
Day 22 (n =5, 7, 5, 6) |
1802
(33)
|
2757
(26)
|
3030
(42)
|
3046
(24)
|
Title | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1 |
---|---|
Description | |
Time Frame | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. |
Arm/Group Title | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg |
---|---|---|---|---|---|---|
Arm/Group Description | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. |
Measure Participants | 5 | 6 | 6 | 7 | 5 | 7 |
Median (Full Range) [hour] |
168
|
120
|
120
|
120
|
120
|
122
|
Title | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 |
---|---|
Description | |
Time Frame | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 |
Outcome Measure Data
Analysis Population Description |
---|
PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|
Arm/Group Description | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 5 | 7 | 7 | 6 |
Day 1 (n =5, 7, 7, 6) |
336
|
336
|
335
|
336
|
Day 22 (n =5, 7, 5, 6) |
48.0
|
72.0
|
72.0
|
60.0
|
Title | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1 |
---|---|
Description | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). |
Time Frame | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. |
Arm/Group Title | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg |
---|---|---|---|---|---|---|
Arm/Group Description | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. |
Measure Participants | 3 | 3 | 4 | 5 | 3 | 3 |
Geometric Mean (Geometric Coefficient of Variation) [nanogram*hour per milliliter (ng*hr/mL)] |
44920
(112)
|
95190
(76)
|
295200
(46)
|
527100
(53)
|
711300
(13)
|
652000
(50)
|
Title | Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 |
---|---|
Description | Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours. |
Time Frame | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22 |
Outcome Measure Data
Analysis Population Description |
---|
PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|
Arm/Group Description | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 5 | 7 | 7 | 6 |
Day 1 (n =5, 7, 7, 6) |
85370
(38)
|
99780
(41)
|
89390
(35)
|
91130
(27)
|
Day 22 (n =5, 7, 5, 6) |
269000
(32)
|
377400
(28)
|
396300
(28)
|
430500
(23)
|
Title | Apparent Clearance (CL/F) of PF-04856883: Stage 1 |
---|---|
Description | It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only. |
Time Frame | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. |
Arm/Group Title | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg |
---|---|---|---|---|---|---|
Arm/Group Description | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. |
Measure Participants | 3 | 3 | 4 | 5 | 3 | 3 |
Geometric Mean (Geometric Coefficient of Variation) [milliliter per hour (mL/hr)] |
89.14
(84)
|
84.08
(59)
|
40.60
(68)
|
34.13
(35)
|
33.73
(14)
|
55.32
(42)
|
Title | Apparent Clearance (CL/F) of PF-04856883: Stage 2 |
---|---|
Description | It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification. |
Time Frame | predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 |
Outcome Measure Data
Analysis Population Description |
---|
PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. |
Arm/Group Title | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|
Arm/Group Description | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 5 | 7 | 7 | 6 |
Geometric Mean (Geometric Coefficient of Variation) [mL/hr] |
44.67
(28)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
Title | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1 |
---|---|
Description | |
Time Frame | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. |
Arm/Group Title | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg |
---|---|---|---|---|---|---|
Arm/Group Description | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. |
Measure Participants | 3 | 3 | 4 | 5 | 3 | 3 |
Geometric Mean (Geometric Coefficient of Variation) [milliliter (mL)] |
18760
(90)
|
21710
(59)
|
9191
(51)
|
7127
(40)
|
8437
(17)
|
10010
(67)
|
Title | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2 |
---|---|
Description | |
Time Frame | predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 |
Outcome Measure Data
Analysis Population Description |
---|
PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. |
Arm/Group Title | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|
Arm/Group Description | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 5 | 7 | 7 | 6 |
Geometric Mean (Geometric Coefficient of Variation) [mL] |
9550
(29)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
Title | Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1 |
---|---|
Description | |
Time Frame | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. |
Arm/Group Title | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg |
---|---|---|---|---|---|---|
Arm/Group Description | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. |
Measure Participants | 3 | 3 | 3 | 4 | 3 | 3 |
Mean (Standard Deviation) [hour] |
146.3
(13.614)
|
179.7
(14.572)
|
147.0
(18.520)
|
133.8
(23.936)
|
173.7
(7.0238)
|
131.6
(45.883)
|
Title | Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2 |
---|---|
Description | |
Time Frame | predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 |
Outcome Measure Data
Analysis Population Description |
---|
PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. |
Arm/Group Title | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|
Arm/Group Description | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 5 | 5 | 4 | 5 |
Mean (Standard Deviation) [hour] |
149.4
(21.870)
|
135.0
(43.980)
|
143.8
(20.565)
|
145.0
(37.000)
|
Title | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 |
---|---|
Description | Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC |
Time Frame | Baseline, Day 3 and 8 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg |
---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. |
Measure Participants | 15 | 5 | 6 | 6 | 7 | 5 | 7 |
Baseline (n =15, 5, 6, 6, 7, 5, 7) |
656.35
(114.496)
|
834.03
(158.952)
|
712.11
(88.942)
|
796.14
(208.733)
|
660.64
(110.833)
|
652.20
(48.707)
|
636.57
(119.662)
|
Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) |
7.72
(89.366)
|
77.82
(125.011)
|
-89.38
(58.909)
|
-101.47
(31.725)
|
-68.05
(111.431)
|
-141.27
(15.975)
|
-153.04
(41.501)
|
Change at Day 8 (n =15, 5, 5, 6, 7, 5, 6) |
-4.82
(75.396)
|
10.37
(158.368)
|
0.85
(125.384)
|
-82.51
(48.898)
|
-28.36
(61.456)
|
-123.43
(68.219)
|
-39.60
(85.256)
|
Title | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 |
---|---|
Description | Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. |
Time Frame | Baseline, Day 3, 15, 24, 29 and 50 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 7 | 5 | 7 | 7 | 6 |
Baseline (n =7, 4, 7, 7, 6) |
606.49
(158.249)
|
811.36
(131.145)
|
756.17
(240.430)
|
800.66
(206.776)
|
723.57
(220.872)
|
Change at Day 3 (n =7, 4, 5, 6, 5) |
44.41
(74.405)
|
-97.03
(55.692)
|
-103.00
(118.759)
|
-98.38
(114.644)
|
-68.52
(153.127)
|
Change at Day 15 (n =7, 4, 6, 6, 6) |
-18.48
(50.874)
|
-265.64
(89.889)
|
-293.04
(163.074)
|
-254.54
(144.897)
|
-240.65
(252.349)
|
Change at Day 24 (n =7, 4, 7, 6, 5) |
-6.20
(46.238)
|
-146.61
(78.863)
|
-207.12
(89.687)
|
-242.35
(231.302)
|
-121.13
(258.528)
|
Change at Day 29 (n =7, 4, 7, 6, 5) |
30.08
(59.490)
|
-55.43
(74.973)
|
-157.54
(88.652)
|
-192.97
(185.056)
|
-106.58
(171.297)
|
Change at Day 50 (n =7, 3, 6, 6, 6) |
50.26
(81.717)
|
-48.82
(80.733)
|
-33.77
(250.859)
|
-125.06
(217.403)
|
-23.99
(123.611)
|
Title | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 |
---|---|
Description | Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. |
Time Frame | Baseline, Day 3 and 8 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg |
---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. |
Measure Participants | 15 | 5 | 6 | 6 | 7 | 5 | 7 |
Baseline (n =15, 5, 6, 6, 7, 5, 7) |
222.18
(139.981)
|
227.07
(142.547)
|
210.80
(95.536)
|
235.84
(130.071)
|
105.34
(19.118)
|
257.73
(127.358)
|
283.59
(156.831)
|
Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) |
68.79
(115.555)
|
22.99
(32.706)
|
35.09
(57.093)
|
12.15
(54.495)
|
59.06
(94.643)
|
83.82
(70.182)
|
13.72
(98.682)
|
Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) |
34.23
(103.279)
|
22.05
(89.419)
|
39.96
(38.941)
|
-50.51
(40.624)
|
38.04
(15.736)
|
-0.36
(50.674)
|
1.08
(47.135)
|
Title | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 |
---|---|
Description | Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. |
Time Frame | Baseline, Day 3, 15, 24, 29 and 50 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 7 | 5 | 7 | 7 | 6 |
Baseline (n =7, 5, 7, 7, 6) |
175.26
(62.218)
|
176.65
(76.040)
|
267.29
(111.497)
|
162.96
(111.688)
|
190.64
(83.945)
|
Change at Day 3 (n =7, 5, 7, 7, 6) |
38.32
(62.135)
|
13.29
(55.764)
|
19.50
(134.651)
|
27.99
(32.655)
|
87.67
(124.052)
|
Change at Day 15 (n =7, 5, 7, 6, 6) |
-16.77
(20.530)
|
-39.16
(42.930)
|
-10.07
(172.044)
|
-51.69
(77.925)
|
-24.36
(85.633)
|
Change at Day 24 (n =7, 4, 7, 6, 6) |
0.23
(55.174)
|
-15.19
(38.900)
|
6.87
(184.830)
|
4.18
(51.903)
|
60.11
(189.287)
|
Change at Day 29 (n =7, 5, 7, 6, 5) |
8.25
(55.799)
|
3.98
(11.218)
|
12.71
(115.095)
|
-1.61
(85.866)
|
15.70
(38.476)
|
Change at Day 50 (n =7, 5, 7, 6, 5) |
8.14
(29.909)
|
-16.64
(33.133)
|
-57.14
(116.193)
|
49.27
(81.874)
|
-26.78
(81.518)
|
Title | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 |
---|---|
Description | Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. |
Time Frame | Baseline, Day 3 and 8 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg |
---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. |
Measure Participants | 15 | 5 | 6 | 6 | 7 | 5 | 7 |
Baseline (n =15, 5, 6, 6, 7,5, 7) |
15.53
(5.332)
|
16.63
(7.743)
|
16.43
(4.306)
|
16.80
(5.711)
|
10.64
(1.156)
|
16.17
(4.531)
|
18.37
(7.395)
|
Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) |
2.15
(3.653)
|
0.69
(1.465)
|
1.65
(4.958)
|
1.05
(1.885)
|
4.30
(4.102)
|
5.34
(2.584)
|
2.34
(4.333)
|
Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) |
0.79
(2.864)
|
1.06
(1.806)
|
0.83
(1.651)
|
-2.74
(1.380)
|
1.70
(1.544)
|
-0.45
(2.883)
|
-0.38
(1.565)
|
Title | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 |
---|---|
Description | Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. |
Time Frame | Baseline, Day 3, 15, 24, 29 and 50 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 7 | 5 | 7 | 7 | 6 |
Baseline (n =7, 5, 7, 7, 6) |
13.47
(4.315)
|
14.59
(4.205)
|
15.63
(4.293)
|
11.74
(5.210)
|
14.14
(5.211)
|
Change at Day 3 (n =7, 5, 7, 7, 6) |
1.68
(2.182)
|
1.89
(4.705)
|
0.50
(4.757)
|
3.16
(1.613)
|
3.49
(4.452)
|
Change at Day 15 (n =7, 5, 7, 6, 6) |
-1.65
(1.493)
|
-1.55
(2.821)
|
-1.92
(6.930)
|
-0.17
(4.135)
|
-0.50
(4.871)
|
Change at Day 24 (n =7, 4, 7, 6, 6) |
0.55
(3.518)
|
0.71
(4.312)
|
-0.99
(6.220)
|
1.63
(2.994)
|
1.21
(5.784)
|
Change at Day 29 (n =7, 5, 7, 6, 5) |
0.10
(3.864)
|
-0.07
(2.545)
|
-0.59
(4.144)
|
0.59
(2.733)
|
0.41
(2.090)
|
Change at Day 50 (n =7, 5, 7, 6, 5) |
-0.17
(1.978)
|
-1.83
(2.015)
|
-4.10
(5.265)
|
1.06
(1.474)
|
-2.90
(3.711)
|
Title | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 |
---|---|
Description | |
Time Frame | Baseline, Day 2, 4, 6, 15, 22 and 29 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 2: PF-04856883 36 mg |
---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. |
Measure Participants | 15 | 5 | 6 | 6 | 7 | 5 | 7 |
Baseline (n =15, 5, 6, 6, 7, 5, 7) |
161.67
(27.102)
|
219.60
(44.557)
|
171.17
(23.752)
|
174.00
(48.949)
|
168.57
(38.336)
|
145.60
(21.606)
|
158.14
(35.362)
|
Change at Day 2 (n =15, 5, 6, 6, 7, 5, 7) |
3.13
(11.807)
|
13.60
(32.393)
|
-18.67
(21.011)
|
-20.50
(20.433)
|
-22.14
(34.090)
|
-35.00
(12.369)
|
-29.71
(30.804)
|
Change at Day 4 (n =15, 5, 5, 6, 7, 5, 6) |
2.73
(17.161)
|
19.60
(35.683)
|
-12.40
(17.358)
|
-10.33
(15.744)
|
-30.71
(13.841)
|
-27.00
(8.803)
|
-28.33
(21.942)
|
Change at Day 6 (n =15, 5, 4, 6, 7, 5, 7) |
18.80
(29.547)
|
26.40
(32.377)
|
10.25
(29.056)
|
-8.33
(27.156)
|
-6.29
(15.850)
|
-16.80
(19.176)
|
-16.14
(22.319)
|
Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) |
12.13
(32.822)
|
-13.80
(46.949)
|
23.80
(56.857)
|
19.33
(16.476)
|
8.00
(21.223)
|
3.40
(27.309)
|
-2.71
(16.530)
|
Change at Day 22 (n =14, 4, 5, 6, 6, 5, 7) |
11.00
(28.205)
|
23.75
(61.163)
|
33.40
(76.064)
|
11.17
(26.446)
|
2.17
(15.065)
|
1.20
(18.847)
|
-0.57
(13.377)
|
Change at Day 29 (n =14, 5, 5, 6, 7, 5, 7) |
22.00
(33.439)
|
1.60
(27.763)
|
27.80
(29.575)
|
0.33
(16.978)
|
1.57
(21.220)
|
-3.80
(22.643)
|
-2.29
(19.551)
|
Title | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 |
---|---|
Description | |
Time Frame | Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 7 | 5 | 7 | 7 | 6 |
Baseline (n =7, 5, 7, 7, 6) |
148.00
(33.317)
|
186.80
(23.059)
|
191.14
(56.153)
|
187.29
(45.756)
|
158.50
(18.447)
|
Change at Day 2 (n =5, 4, 7, 7, 5) |
3.00
(15.281)
|
-26.75
(15.108)
|
-15.14
(21.217)
|
-23.43
(35.142)
|
-10.40
(18.461)
|
Change at Day 4 (n =5, 5, 7, 6, 6) |
7.60
(6.427)
|
-14.80
(24.284)
|
-14.86
(48.657)
|
-20.33
(22.818)
|
-1.50
(27.384)
|
Change at Day 6 (n =7, 4, 7, 7, 6) |
-1.71
(40.240)
|
5.75
(14.080)
|
-44.86
(38.451)
|
-8.00
(42.942)
|
-15.83
(8.909)
|
Change at Day 8 (n =6, 5, 7, 5, 6) |
2.50
(17.627)
|
4.20
(19.967)
|
-37.43
(42.383)
|
2.60
(73.449)
|
24.50
(47.618)
|
Change at Day 22 (n =7, 4, 7, 6, 6) |
13.29
(15.294)
|
-4.25
(13.817)
|
-39.57
(25.468)
|
-14.17
(38.270)
|
-0.33
(51.181)
|
Change at Day 23 (n =7, 4, 6, 6, 5) |
7.71
(23.894)
|
-27.25
(27.293)
|
-40.33
(18.327)
|
-17.50
(73.519)
|
-24.00
(29.967)
|
Change at Day 25 (n =7, 5, 6, 6, 5) |
13.43
(13.113)
|
-16.60
(43.443)
|
-44.67
(27.667)
|
-23.33
(52.936)
|
-16.20
(36.513)
|
Change at Day 27 (n =7, 5, 6, 6, 5) |
8.57
(21.110)
|
-21.60
(15.821)
|
-37.33
(17.963)
|
-34.67
(35.803)
|
12.00
(71.039)
|
Change at Day 30 (n =7, 5, 7, 6, 5) |
2.43
(12.739)
|
-14.20
(17.908)
|
-22.29
(26.171)
|
-9.33
(32.898)
|
15.40
(37.964)
|
Change at Day 36 (n =6, 5, 7, 6, 6) |
-10.50
(32.415)
|
0.40
(37.846)
|
1.86
(25.373)
|
-5.83
(32.009)
|
27.67
(59.594)
|
Change at Day 43 (n =7, 5, 5, 6, 6) |
18.71
(22.552)
|
12.80
(29.064)
|
13.20
(17.254)
|
-1.17
(41.787)
|
8.33
(18.991)
|
Title | Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 |
---|---|
Description | A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured. |
Time Frame | Baseline, Day 30 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 7 | 5 | 7 | 7 | 6 |
Baseline (n =7, 5, 7, 7 ,6) |
166.19
(35.437)
|
212.43
(52.764)
|
205.56
(51.907)
|
202.43
(38.900)
|
186.13
(33.839)
|
Change at Day 30 (n =7, 5, 7, 6 ,5) |
172.36
(38.825)
|
191.20
(43.953)
|
172.24
(48.067)
|
174.08
(41.437)
|
192.87
(58.037)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg |
---|---|---|
Comments | Day 30 | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.219 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | Least square (LS) mean |
Estimated Value | -21.16 | |
Confidence Interval |
(2-Sided) 80% -43.26 to 0.93 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 16.766 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg |
---|---|---|
Comments | Day 30 | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.034 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean |
Estimated Value | -34.18 | |
Confidence Interval |
(2-Sided) 80% -54.20 to -14.16 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 15.189 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg |
---|---|---|
Comments | Day 30 | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.044 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean |
Estimated Value | -33.67 | |
Confidence Interval |
(2-Sided) 80% -54.50 to -12.84 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 15.806 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg |
---|---|---|
Comments | Day 30 | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.857 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean |
Estimated Value | -2.93 | |
Confidence Interval |
(2-Sided) 80% -24.16 to 18.31 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 16.111 |
|
Estimation Comments |
Title | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 |
---|---|
Description | HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2. |
Time Frame | Baseline, Day 29 and 50 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 7 | 5 | 7 | 7 | 6 |
Day 29 (n =7, 5, 7, 6, 5) |
0.06
(0.547)
|
-0.24
(0.288)
|
-0.41
(0.212)
|
-0.42
(0.440)
|
-0.40
(0.430)
|
Day 50 (n =6, 5, 7, 7, 6) |
0.15
(0.769)
|
-0.08
(0.335)
|
-0.24
(0.326)
|
-0.33
(0.754)
|
-0.40
(0.580)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg |
---|---|---|
Comments | Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.419 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -0.21 | |
Confidence Interval |
(2-Sided) 80% -0.54 to 0.12 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.251 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg |
---|---|---|
Comments | Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.077 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -0.41 | |
Confidence Interval |
(2-Sided) 80% -0.71 to -0.12 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.224 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg |
---|---|---|
Comments | Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.147 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -0.34 | |
Confidence Interval |
(2-Sided) 80% -0.65 to -0.04 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.230 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg |
---|---|---|
Comments | Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.086 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -0.43 | |
Confidence Interval |
(2-Sided) 80% -0.76 to -0.11 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.244 |
|
Estimation Comments |
Title | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 |
---|---|
Description | |
Time Frame | Baseline, Day 8, 15 and 29 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24mg | Stage 1: PF-04856883 36 mg |
---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. |
Measure Participants | 15 | 5 | 6 | 6 | 7 | 5 | 7 |
Baseline (n =15, 5, 6, 6, 7, 5, 7) |
270.60
(34.618)
|
289.20
(48.329)
|
279.67
(30.507)
|
304.83
(45.155)
|
263.43
(34.942)
|
259.80
(53.644)
|
273.71
(36.036)
|
Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) |
1.13
(14.461)
|
20.20
(10.986)
|
4.20
(18.295)
|
5.67
(13.095)
|
4.29
(16.720)
|
-13.60
(23.554)
|
-12.29
(10.579)
|
Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) |
-5.67
(17.839)
|
-20.40
(25.393)
|
-16.40
(13.502)
|
-9.17
(25.135)
|
13.33
(24.188)
|
-9.60
(22.267)
|
-3.00
(11.165)
|
Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) |
0.93
(19.627)
|
8.40
(30.876)
|
7.20
(29.660)
|
-4.50
(16.109)
|
15.86
(24.024)
|
1.40
(17.344)
|
-4.43
(18.867)
|
Title | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 |
---|---|
Description | |
Time Frame | Baseline, Day 8, 15, 22, 29 and 50 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 7 | 5 | 7 | 7 | 6 |
Baseline (n =7, 5, 7, 7, 6) |
281.14
(57.875)
|
309.40
(47.600)
|
301.14
(43.690)
|
291.29
(37.911)
|
303.67
(47.272)
|
Change at Day 8 (n =7, 5, 7, 6, 6) |
-5.29
(19.678)
|
-8.20
(11.100)
|
-12.14
(12.668)
|
-9.17
(23.043)
|
-10.17
(21.720)
|
Change at Day 15 (n =7, 5, 7, 6, 6) |
-1.86
(21.146)
|
-8.20
(15.707)
|
-39.29
(21.077)
|
-11.67
(24.047)
|
-14.67
(33.037)
|
Change at Day 22 (n =7, 5, 7, 6, 6) |
-7.43
(13.176)
|
-18.20
(20.462)
|
-37.86
(19.945)
|
-24.67
(20.925)
|
-27.50
(25.399)
|
Change at Day 29 (n =7, 5, 7, 6, 4) |
-4.43
(27.098)
|
-26.60
(22.612)
|
-37.57
(14.976)
|
-32.67
(28.507)
|
-41.00
(29.855)
|
Change at Day 50 (n =7, 5, 7, 7, 6) |
-6.86
(20.732)
|
-8.80
(14.446)
|
-6.43
(20.871)
|
-12.43
(26.732)
|
-5.67
(31.258)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg |
---|---|---|
Comments | Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.663 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 4.11 | |
Confidence Interval |
(2-Sided) 80% -8.16 to 16.37 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.326 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg |
---|---|---|
Comments | Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.825 |
Comments | ||
Method | mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -1.89 | |
Confidence Interval |
(2-Sided) 80% -13.03 to 9.25 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.472 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg |
---|---|---|
Comments | Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.878 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 1.36 | |
Confidence Interval |
(2-Sided) 80% -10.20 to 12.92 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.791 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg |
---|---|---|
Comments | Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.936 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 0.72 | |
Confidence Interval |
(2-Sided) 80% -10.89 to 12.33 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.829 |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg |
---|---|---|
Comments | Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.959 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 0.68 | |
Confidence Interval |
(2-Sided) 80% -16.46 to 17.82 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 13.037 |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg |
---|---|---|
Comments | Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.011 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -32.46 | |
Confidence Interval |
(2-Sided) 80% -48.07 to -16.85 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 11.872 |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg |
---|---|---|
Comments | Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.833 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -2.61 | |
Confidence Interval |
(2-Sided) 80% -18.67 to 13.45 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 12.212 |
|
Estimation Comments |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg |
---|---|---|
Comments | Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.565 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -7.21 | |
Confidence Interval |
(2-Sided) 80% -23.47 to 9.05 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 12.365 |
|
Estimation Comments |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg |
---|---|---|
Comments | Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.703 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -3.75 | |
Confidence Interval |
(2-Sided) 80% -16.52 to 9.02 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.713 |
|
Estimation Comments |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg |
---|---|---|
Comments | Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.008 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -25.46 | |
Confidence Interval |
(2-Sided) 80% -37.07 to -13.85 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.827 |
|
Estimation Comments |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg |
---|---|---|
Comments | Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.253 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -10.60 | |
Confidence Interval |
(2-Sided) 80% -22.51 to 1.32 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.061 |
|
Estimation Comments |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg |
---|---|---|
Comments | Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.128 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -14.47 | |
Confidence Interval |
(2-Sided) 80% -26.57 to -2.38 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.198 |
|
Estimation Comments |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg |
---|---|---|
Comments | Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.196 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -15.15 | |
Confidence Interval |
(2-Sided) 80% -30.17 to -0.13 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 11.421 |
|
Estimation Comments |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg |
---|---|---|
Comments | Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.012 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -28.17 | |
Confidence Interval |
(2-Sided) 80% -41.84 to -14.51 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.393 |
|
Estimation Comments |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg |
---|---|---|
Comments | Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.047 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -22.48 | |
Confidence Interval |
(2-Sided) 80% -36.65 to -8.32 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.773 |
|
Estimation Comments |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg |
---|---|---|
Comments | Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.023 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -28.63 | |
Confidence Interval |
(2-Sided) 80% -44.19 to -13.06 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 11.837 |
|
Estimation Comments |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg |
---|---|---|
Comments | Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.711 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 5.08 | |
Confidence Interval |
(2-Sided) 80% -12.77 to 22.93 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 13.576 |
|
Estimation Comments |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg |
---|---|---|
Comments | Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.666 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 5.40 | |
Confidence Interval |
(2-Sided) 80% -10.86 to 21.66 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 12.365 |
|
Estimation Comments |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg |
---|---|---|
Comments | Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.807 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -3.05 | |
Confidence Interval |
(2-Sided) 80% -19.27 to 13.17 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 12.333 |
|
Estimation Comments |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg |
---|---|---|
Comments | Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.603 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 6.79 | |
Confidence Interval |
(2-Sided) 80% -10.15 to 23.72 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 12.877 |
|
Estimation Comments |
Title | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 |
---|---|
Description | |
Time Frame | Baseline, Day 8, 15 and 29 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg |
---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. |
Measure Participants | 15 | 5 | 6 | 6 | 7 | 5 | 7 |
Baseline (n =15, 5, 6, 6, 7, 5, 7) |
8.17
(5.021)
|
5.02
(2.831)
|
5.77
(1.306)
|
5.35
(3.683)
|
6.20
(5.440)
|
12.04
(5.133)
|
11.84
(8.122)
|
Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) |
0.39
(0.895)
|
-0.36
(0.727)
|
0.64
(0.639)
|
0.15
(0.596)
|
0.73
(0.632)
|
0.00
(1.584)
|
0.97
(0.629)
|
Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) |
0.38
(1.047)
|
0.42
(1.711)
|
1.50
(1.321)
|
-0.32
(1.143)
|
1.07
(1.111)
|
0.32
(1.608)
|
1.17
(0.780)
|
Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) |
0.46
(1.608)
|
-0.36
(0.820)
|
-0.52
(3.192)
|
-0.62
(1.492)
|
0.97
(1.467)
|
0.36
(1.499)
|
0.66
(1.110)
|
Title | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 |
---|---|
Description | |
Time Frame | Baseline, Day 8, 15, 22, 29 and 50 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 7 | 5 | 7 | 7 | 6 |
Baseline (n =7, 5, 7, 7, 6) |
7.66
(4.351)
|
6.32
(3.517)
|
8.09
(6.240)
|
7.59
(5.538)
|
3.95
(1.291)
|
Change at Day 8 (n =7, 5, 7, 6, 6) |
-0.10
(0.663)
|
0.40
(0.962)
|
0.41
(0.570)
|
-0.08
(1.599)
|
0.90
(0.502)
|
Change at Day 15 (n =7, 5, 7, 6, 6) |
-0.03
(1.376)
|
0.72
(1.512)
|
1.21
(0.641)
|
0.32
(2.483)
|
0.63
(1.481)
|
Change at Day 22 (n =7, 5, 7, 6, 6) |
0.13
(1.289)
|
1.14
(0.518)
|
1.73
(1.034)
|
0.95
(3.086)
|
1.28
(2.046)
|
Change at Day 29 (n =7, 5, 7, 6, 5) |
0.36
(1.765)
|
1.46
(0.730)
|
1.83
(1.241)
|
1.50
(2.900)
|
1.60
(2.827)
|
Change at Day 50 (n =7, 5, 7, 7, 6) |
0.40
(2.106)
|
0.38
(2.381)
|
-0.30
(1.294)
|
1.64
(2.985)
|
0.92
(2.076)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg |
---|---|---|
Comments | Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.387 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 0.48 | |
Confidence Interval |
(2-Sided) 80% -0.24 to 1.21 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.551 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg |
---|---|---|
Comments | Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.309 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 0.52 | |
Confidence Interval |
(2-Sided) 80% -0.14 to 1.18 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.501 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg |
---|---|---|
Comments | Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.956 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -0.03 | |
Confidence Interval |
(2-Sided) 80% -0.71 to 0.65 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.518 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg |
---|---|---|
Comments | Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.089 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 0.96 | |
Confidence Interval |
(2-Sided) 80% 0.24 to 1.67 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.542 |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg |
---|---|---|
Comments | Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.434 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 0.73 | |
Confidence Interval |
(2-Sided) 80% -0.48 to 1.95 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.923 |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg |
---|---|---|
Comments | Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.150 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 1.25 | |
Confidence Interval |
(2-Sided) 80% 0.14 to 2.35 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.841 |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg |
---|---|---|
Comments | Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.752 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 0.27 | |
Confidence Interval |
(2-Sided) 80% -0.86 to 1.41 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.861 |
|
Estimation Comments |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg |
---|---|---|
Comments | Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.492 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 0.62 | |
Confidence Interval |
(2-Sided) 80% -0.55 to 1.79 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.888 |
|
Estimation Comments |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg |
---|---|---|
Comments | Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.358 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 1.00 | |
Confidence Interval |
(2-Sided) 80% -0.40 to 2.40 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.064 |
|
Estimation Comments |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg |
---|---|---|
Comments | Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.110 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean Difference |
Estimated Value | 1.60 | |
Confidence Interval |
(2-Sided) 80% 0.33 to 2.88 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.970 |
|
Estimation Comments |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg |
---|---|---|
Comments | Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.461 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean Difference |
Estimated Value | 0.74 | |
Confidence Interval |
(2-Sided) 80% -0.56 to 2.05 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.993 |
|
Estimation Comments |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg |
---|---|---|
Comments | Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.286 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean Difference |
Estimated Value | 1.11 | |
Confidence Interval |
(2-Sided) 80% -0.23 to 2.45 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.021 |
|
Estimation Comments |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg |
---|---|---|
Comments | Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.362 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 1.09 | |
Confidence Interval |
(2-Sided) 80% -0.45 to 2.63 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.172 |
|
Estimation Comments |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg |
---|---|---|
Comments | Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.179 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 1.48 | |
Confidence Interval |
(2-Sided) 80% 0.07 to 2.88 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.069 |
|
Estimation Comments |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg |
---|---|---|
Comments | Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.342 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 1.06 | |
Confidence Interval |
(2-Sided) 80% -0.38 to 2.49 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.092 |
|
Estimation Comments |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg |
---|---|---|
Comments | Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.272 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 1.27 | |
Confidence Interval |
(2-Sided) 80% -0.22 to 2.75 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.129 |
|
Estimation Comments |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg |
---|---|---|
Comments | Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.979 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -0.04 | |
Confidence Interval |
(2-Sided) 80% -1.77 to 1.70 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.317 |
|
Estimation Comments |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg |
---|---|---|
Comments | Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.568 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -0.70 | |
Confidence Interval |
(2-Sided) 80% -2.27 to 0.88 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.201 |
|
Estimation Comments |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg |
---|---|---|
Comments | Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.311 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 1.24 | |
Confidence Interval |
(2-Sided) 80% -0.34 to 2.82 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.201 |
|
Estimation Comments |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg |
---|---|---|
Comments | Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.710 |
Comments | ||
Method | Mixed meal tolerance test | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 0.47 | |
Confidence Interval |
(2-Sided) 80% -1.18 to 2.13 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.260 |
|
Estimation Comments |
Title | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 |
---|---|
Description | |
Time Frame | Day 1 and 29 |
Outcome Measure Data
Analysis Population Description |
---|
Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg |
---|---|---|---|---|---|---|
Arm/Group Description | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. |
Measure Participants | 5 | 6 | 6 | 7 | 5 | 7 |
Day 1 (n =5, 6, 6, 7, 5, 7) |
1
6.7%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
2
40%
|
Day 29 (n =5, 5, 6, 6, 5, 7) |
1
6.7%
|
2
40%
|
1
16.7%
|
0
0%
|
0
0%
|
2
40%
|
Title | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 |
---|---|
Description | |
Time Frame | Day 1, 29 and 50 |
Outcome Measure Data
Analysis Population Description |
---|
Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. |
Arm/Group Title | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
---|---|---|---|---|
Arm/Group Description | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
Measure Participants | 5 | 7 | 7 | 6 |
Day 1 (n =5, 7, 7, 6) |
0
0%
|
1
20%
|
1
16.7%
|
0
0%
|
Day 29 (n =5, 7, 6, 5) |
0
0%
|
2
40%
|
2
33.3%
|
1
16.7%
|
Day 50 (n =5, 7, 6, 6) |
0
0%
|
3
60%
|
2
33.3%
|
3
50%
|
Adverse Events
Time Frame | ||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||||||||||||||||||
Arm/Group Title | Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg | Stage 2: Placebo | Stage 2: PF-04856883 12.0 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | ||||||||||||
Arm/Group Description | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | Participants received PF-04856883 4 milligram (mg) subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12.0 mg subcutaneous injection on Day 1, 8, 15 and 22 in Stage 2. | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | ||||||||||||
All Cause Mortality |
||||||||||||||||||||||||
Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg | Stage 2: Placebo | Stage 2: PF-04856883 12.0 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | |||||||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||
Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg | Stage 2: Placebo | Stage 2: PF-04856883 12.0 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | |||||||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||
Stage 1: PF-04856883 Placebo | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg | Stage 2: Placebo | Stage 2: PF-04856883 12.0 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | |||||||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 8/15 (53.3%) | 1/5 (20%) | 0/6 (0%) | 2/6 (33.3%) | 4/7 (57.1%) | 3/5 (60%) | 4/7 (57.1%) | 4/7 (57.1%) | 5/5 (100%) | 5/7 (71.4%) | 5/7 (71.4%) | 5/6 (83.3%) | ||||||||||||
Blood and lymphatic system disorders | ||||||||||||||||||||||||
Anaemia | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 1/5 (20%) | 1/7 (14.3%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Cardiac disorders | ||||||||||||||||||||||||
Palpitations | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/6 (0%) | ||||||||||||
Ear and labyrinth disorders | ||||||||||||||||||||||||
Ear pain | 1/15 (6.7%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Eye disorders | ||||||||||||||||||||||||
Conjunctival hyperaemia | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 1/6 (16.7%) | ||||||||||||
Gastrointestinal disorders | ||||||||||||||||||||||||
Abdominal distension | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 0/7 (0%) | 1/5 (20%) | 2/7 (28.6%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Abdominal pain | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Abdominal pain upper | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Diarrhoea | 2/15 (13.3%) | 0/5 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 2/7 (28.6%) | 1/5 (20%) | 2/7 (28.6%) | 2/7 (28.6%) | 3/6 (50%) | ||||||||||||
Nausea | 2/15 (13.3%) | 0/5 (0%) | 0/6 (0%) | 1/6 (16.7%) | 3/7 (42.9%) | 2/5 (40%) | 2/7 (28.6%) | 3/7 (42.9%) | 2/5 (40%) | 3/7 (42.9%) | 4/7 (57.1%) | 3/6 (50%) | ||||||||||||
Vomiting | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 3/7 (42.9%) | 3/5 (60%) | 3/7 (42.9%) | 2/7 (28.6%) | 2/5 (40%) | 2/7 (28.6%) | 3/7 (42.9%) | 3/6 (50%) | ||||||||||||
Abdominal discomfort | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 1/5 (20%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Constipation | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 3/7 (42.9%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Dyspepsia | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 1/6 (16.7%) | ||||||||||||
Faecal volume increased | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/6 (0%) | ||||||||||||
Faeces discoloured | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/6 (0%) | ||||||||||||
Gastritis | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 1/5 (20%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Gastrooesophageal reflux disease | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Haematemesis | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Lip swelling | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 1/6 (16.7%) | ||||||||||||
Toothache | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
General disorders | ||||||||||||||||||||||||
Asthenia | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 1/7 (14.3%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Injection site reaction | 1/15 (6.7%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 1/5 (20%) | 0/7 (0%) | 0/7 (0%) | 1/6 (16.7%) | ||||||||||||
Chest pain | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 1/5 (20%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Fatigue | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 1/5 (20%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Oedema peripheral | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Local swelling | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Infections and infestations | ||||||||||||||||||||||||
Urinary tract infection | 0/15 (0%) | 1/5 (20%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Gastroenteritis | 1/15 (6.7%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Subcutaneous abscess | 1/15 (6.7%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Tinea cruris | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Upper respiratory tract infection | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 1/6 (16.7%) | ||||||||||||
Injury, poisoning and procedural complications | ||||||||||||||||||||||||
Arthropod bite | 1/15 (6.7%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Ligament sprain | 1/15 (6.7%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Periorbital haematoma | 1/15 (6.7%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Investigations | ||||||||||||||||||||||||
Blood uric acid increased | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Heart rate increased | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Metabolism and nutrition disorders | ||||||||||||||||||||||||
Decreased appetite | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 4/5 (80%) | 1/7 (14.3%) | 0/7 (0%) | 1/6 (16.7%) | ||||||||||||
Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||
Arthralgia | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Bone pain | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Musculoskeletal pain | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 1/5 (20%) | 1/7 (14.3%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Myalgia | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Neck pain | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Pain in jaw | 1/15 (6.7%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Nervous system disorders | ||||||||||||||||||||||||
Dizziness | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 0/7 (0%) | 1/5 (20%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Headache | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 2/7 (28.6%) | 3/7 (42.9%) | 2/5 (40%) | 4/7 (57.1%) | 3/7 (42.9%) | 3/6 (50%) | ||||||||||||
Psychiatric disorders | ||||||||||||||||||||||||
Depressed mood | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Insomnia | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 1/5 (20%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Renal and urinary disorders | ||||||||||||||||||||||||
Chromaturia | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Micturition urgency | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/6 (0%) | ||||||||||||
Reproductive system and breast disorders | ||||||||||||||||||||||||
Pruritus genital | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||
Oropharyngeal pain | 1/15 (6.7%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Cough | 1/15 (6.7%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Respiratory tract congestion | 1/15 (6.7%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||
Cold sweat | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/6 (0%) | ||||||||||||
Dermatitis | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Hyperhidrosis | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Petechiae | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Pruritus generalised | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/6 (0%) | ||||||||||||
Rash papular | 1/15 (6.7%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 0/7 (0%) | 0/6 (0%) | ||||||||||||
Vascular disorders | ||||||||||||||||||||||||
Hypertension | 0/15 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/7 (0%) | 0/5 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/5 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/6 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title | Pfizer ClinicalTrials.gov |
---|---|
Organization | Pfizer, Inc. |
Phone | 1-800-718-1021 |
ClinicalTrials.gov_Inquiries@pfizer.com |
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