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A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00886821
Collaborator
(none)
114
Enrollment
2
Locations
1
Arm
32
Duration (Months)
57
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.

Condition or Disease Intervention/Treatment Phase
  • Biological: CVX-096
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Escalating Subcutaneous Doses Of Cvx-096 In Type 2 Diabetic Adult Subjects
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Biological: CVX-096
Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg

Outcome Measures

Primary Outcome Measures

  1. Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1 [pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1]

    AUClast was defined as area under the concentration-time curve from time zero to the time of last measured concentration and calculated by using linear up/log down trapezoidal method.

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1 [Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1]

  3. Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8 [pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8]

  4. Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22 [pre-dose, 1 and 6 hours post-dose on Day 22]

  5. Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1 [Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1]

  6. Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8 [pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8]

  7. Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22 [pre-dose, 1 and 6 hours post-dose on Day 22]

Secondary Outcome Measures

  1. Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1 [pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1]

    Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.

  2. Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8 [pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8]

    Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.

  3. Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22 [pre-dose, 1 and 6 hours post-dose on Day 22]

    Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.

  4. Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1 [pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1]

    MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method and AUC(0 - inf) is the area under the concentration-time curve extrapolated to infinity.

  5. Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1 [pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1]

    Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug apparent oral clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  6. Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1 [pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1]

    AUC(0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It was calculated as AUC (0-t) plus (last measurable concentration divided by apparent terminal elimination rate constant).

Other Outcome Measures

  1. Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Cohort 1-8: Baseline up to Day 29; Cohort 9: Baseline up to Day 36; Cohort 10-12: 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 that were absent before treatment or that worsened relative to pretreatment state.

  2. Stage 1: Change From Baseline in Post-Prandial Area Under the Curve (AUC) of Glucose at Day 3 and 7 [Baseline, Day 3 and 7]

    Area under the glucose concentration-time curve from 0 minute (approximately 20 minutes prior to the meal) to 180 minutes post initiation of meal.

  3. Stage 1: Change From Baseline in 7-point Weighted Mean Glucose at Day 3 and Day 7 [Baseline, Day 3 and 7]

    It was assessed by 7-point glucose measurements via the glucose oxidase method.

  4. Number of Participants With Clinically Significant Laboratory Abnormalities [Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50]

    Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit: less than (<) 0.8*lower limit of normal (LLN), platelet: <75 or greater than (>) 700*10^3/millimeter (mm)^3*upper limit of normal (ULN), leukocyte: <2.5 or >17.5*10^3/mm^3*ULN; total bilirubin 1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase: >3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN ;blood urea nitrogen, creatinine: >1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, calcium: <0.9*LLN or >1.1*ULN, albumin, total protein <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, creatine kinase >2.0*ULN; urine (red blood cell, white blood cell >6/high power field).

  5. Number of Participants With Clinically Significant Vital Signs [Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50]

    Criteria for vital signs: pulse rate <40 beats per minute (bpm), supine, sitting and erect pulse rate <40 bpm, supine pulse rate >120 bpm, sitting pulse rate >120 bpm, and erect pulse rate >120 bpm; systolic blood pressure: SBP <90 millimeters of mercury (mmHg), change from baseline in SBP greater than or equal to (>=) 30 mmHg; diastolic blood pressure: DBP <50 mmHg, change from baseline in DBP >=20 mmHg.

  6. Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings [Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50]

    Criteria for ECG findings: PR interval >=300 millisecond (msec), >=25 percent increase when baseline >200 msec, and >=50 percent increase when baseline less than or equal to (<=) 200 msec; QRS interval >=200 msec, >=25 percent increase when baseline >=100 msec, and >=50 percent increase when baseline <=100 msec; QT/QTc interval (corrected QT interval) >=500 msec.

  7. Number of Participants With Clinically Significant Physical Examinations [Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50]

    Full physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator.

  8. Stage 1: Number of Participants With Hypoglycemia [Day 1: 0 hour (pre-dose) up to 48 hours post dose]

    Blood glucose level was checked for hypoglycemia by glucometer. Criteria for hypoglycemia: blood glucose level <60 mg/dL if accompanied by symptoms, blood glucose level <=50 mg/dL regardless of symptoms.

  9. Stage 1: Number of Participants With Clinically Significant Abnormal Rhythms [Cohort 1- 8: Day 1 up to Day 3; Cohort 9: Day 1 up to Day 10]

    Criteria for abnormal rhythms: asymptomatic marked sinus bradycardia rate <35 bpm; asymptomatic supraventricular couplets, atrial bigeminy lasting >30 seconds; asymptomatic ventricular couplets, ventricular bigeminy lasting >30 seconds; asymptomatic type I second degree (wenckebach) atrioventricular block of >30 seconds duration; asymptomatic frequent premature ventricular complexes (=>200/24 hours); asymptomatic frequent premature atrial complexes (=>240/24 hours).

  10. Stage 1: Number of Participants With Anti-Drug Antibodies [Day 0, 8, 14, 15, 21, 28 and 35]

  11. Stage 2: Number of Participants With Anti-Drug Antibodies [Day 0, 29 and 50]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male and/or female patients (females will be women of non-childbearing potential) with an historical diagnosis of type 2 diabetes mellitus, who are currently being treated with metformin at a dose at or near maximum.

  • Hb A1c between 7-10%.

  • Fasting C-peptide >0.4 nmol/L.

Exclusion Criteria:

  • History of clinically significant chronic conditions other than T2DM not well controlled by either diet or medications.

  • Patients with pancreatitis or considered a high risk for pancreatitis.

  • History of contraindications to metformin therapy.

  • Previous treatment with an approved or investigational GLP 1 mimetic.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cetero Research Miami Gardens Florida United States 33169
2 Cetero Research - San Antonio San Antonio Texas United States 78229

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.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00886821
Other Study ID Numbers:
  • B1111001
  • CVX-096-101
First Posted:
Apr 23, 2009
Last Update Posted:
Apr 18, 2017
Last Verified:
Mar 1, 2017
Keywords provided by Pfizer
Phase 1 Type 2 diabetes CVX-096 diabetes mellitus
adult-onset diabetes mellitus
non-insulin dependent
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail Study consist of two stages: stage 1 and stage 2. Participants were enrolled and randomized for stage 1 and stage 2 separately.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-9: Placebo Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg Cohort 10-12: Placebo
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively. Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
Period Title: Stage 1
STARTED 7 6 6 7 6 6 6 6 6 18 0 0 0 0
COMPLETED 7 6 6 7 6 6 6 6 6 18 0 0 0 0
NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Stage 1
STARTED 0 0 0 0 0 0 0 0 0 0 9 9 13 9
COMPLETED 0 0 0 0 0 0 0 0 0 0 9 8 8 8
NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 0 1 5 1

Baseline Characteristics

Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 9: Placebo Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg Cohort 10-12: Placebo Total
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or two dose on Day 1 and 8 respectively. Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22. Total of all reporting groups
Overall Participants 7 6 6 7 6 6 6 6 6 18 9 9 13 9 114
Age (Count of Participants)
<=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%
0
0%
0
0%
Between 18 and 65 years
7
100%
6
100%
6
100%
7
100%
6
100%
5
83.3%
5
83.3%
4
66.7%
5
83.3%
13
72.2%
8
88.9%
8
88.9%
13
100%
8
88.9%
101
88.6%
>=65 years
0
0%
0
0%
0
0%
0
0%
0
0%
1
16.7%
1
16.7%
2
33.3%
1
16.7%
5
27.8%
1
11.1%
1
11.1%
0
0%
1
11.1%
13
11.4%
Sex: Female, Male (Count of Participants)
Female
0
0%
3
50%
1
16.7%
5
71.4%
3
50%
2
33.3%
5
83.3%
6
100%
0
0%
3
16.7%
4
44.4%
4
44.4%
3
23.1%
0
0%
39
34.2%
Male
7
100%
3
50%
5
83.3%
2
28.6%
3
50%
4
66.7%
1
16.7%
0
0%
6
100%
15
83.3%
5
55.6%
5
55.6%
10
76.9%
9
100%
75
65.8%

Outcome Measures

1. Primary Outcome
Title Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1
Description AUClast was defined as area under the concentration-time curve from time zero to the time of last measured concentration and calculated by using linear up/log down trapezoidal method.
Time Frame pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1

Outcome Measure Data

Analysis Population Description
Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. 'N'(Overall number of participants)=participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort(Cohort 9),as pre-specified in protocol.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
Measure Participants 4 6 6 6 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation) [nanogram*hour per milliliter (ng*hr)/mL]
865
(625.3)
4960
(462.0)
7065
(192.1)
32552
(127.7)
105950
(53.4)
304167
(25.9)
120521
(5404.6)
297503
(211.1)
2. Primary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1
Description
Time Frame Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1

Outcome Measure Data

Analysis Population Description
PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
Measure Participants 4 6 6 6 6 6 6 6 6 9 9 13
Median (Full Range) [hour]
156
72.1
168
72.0
144
120
108
96.0
84.0
168
168
168
3. Primary Outcome
Title Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8
Description
Time Frame pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8

Outcome Measure Data

Analysis Population Description
PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.
Arm/Group Title Cohort 9: PF-04856883 18.0 mg
Arm/Group Description Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
Measure Participants 6
Median (Full Range) [hour]
72.0
4. Primary Outcome
Title Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22
Description
Time Frame pre-dose, 1 and 6 hours post-dose on Day 22

Outcome Measure Data

Analysis Population Description
PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg
Arm/Group Description Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
Measure Participants 9 7 7
Median (Full Range) [hour]
48.0
46.9
48.0
5. Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1
Description
Time Frame Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1

Outcome Measure Data

Analysis Population Description
PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
Measure Participants 4 6 6 6 6 6 6 6 6 9 9 13
Geometric Mean (Geometric Coefficient of Variation) [nanogram per milliliter (ng/mL)]
7.05
(104.9)
29.0
(126.3)
24.8
(92.3)
149
(63.2)
387
(52.4)
900
(36.2)
579
(1314.6)
1299
(104.3)
1082
(50.0)
736
(47.1)
1554
(38.3)
958
(63.1)
6. Primary Outcome
Title Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8
Description
Time Frame pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8

Outcome Measure Data

Analysis Population Description
PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.
Arm/Group Title Cohort 9: PF-04856883 18.0 mg
Arm/Group Description Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
Measure Participants 6
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]
1536
(54.9)
7. Primary Outcome
Title Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22
Description
Time Frame pre-dose, 1 and 6 hours post-dose on Day 22

Outcome Measure Data

Analysis Population Description
PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg
Arm/Group Description Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
Measure Participants 9 8 7
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]
1767
(37.6)
2193
(36.9)
2253
(31.9)
8. Secondary Outcome
Title Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1
Description Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
Time Frame pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1

Outcome Measure Data

Analysis Population Description
PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
Measure Participants 4 4 3 5 5 6 5 4
Mean (Standard Deviation) [hour]
NA
(NA)
188
(42.6)
151
(5.14)
186
(53.3)
144
(12.0)
163
(52.0)
156
(45.6)
159
(37.5)
9. Secondary Outcome
Title Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8
Description Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
Time Frame pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8

Outcome Measure Data

Analysis Population Description
PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.
Arm/Group Title Cohort 9: PF-04856883 18.0 mg
Arm/Group Description Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
Measure Participants 6
Mean (Standard Deviation) [hour]
156
(23.4)
10. Secondary Outcome
Title Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22
Description Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
Time Frame pre-dose, 1 and 6 hours post-dose on Day 22

Outcome Measure Data

Analysis Population Description
PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg
Arm/Group Description Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
Measure Participants 8 8 5
Mean (Standard Deviation) [hour]
156
(32.7)
102
(44.9)
149
(29.0)
11. Secondary Outcome
Title Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1
Description MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method and AUC(0 - inf) is the area under the concentration-time curve extrapolated to infinity.
Time Frame pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1

Outcome Measure Data

Analysis Population Description
PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
Measure Participants 4 4 3 5 5 6 5 4
Median (Full Range) [hour]
NA
310
(69.4)
316
(20.3)
350
(70.5)
281
(31.6)
319
(77.8)
239
(89.7)
312
(70.7)
12. Secondary Outcome
Title Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1
Description Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug apparent oral clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time Frame pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1

Outcome Measure Data

Analysis Population Description
PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
Measure Participants 4 4 3 5 5 6 5 4
Geometric Mean (Geometric Coefficient of Variation) [Liter per hour (L/hr)]
NA
(NA)
0.0176
(20.4)
0.0643
(27.4)
0.0562
(36.5)
0.0487
(53.5)
0.0354
(25.6)
0.0530
(47.5)
0.0527
(28.6)
13. Secondary Outcome
Title Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1
Description AUC(0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It was calculated as AUC (0-t) plus (last measurable concentration divided by apparent terminal elimination rate constant).
Time Frame pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1

Outcome Measure Data

Analysis Population Description
PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
Measure Participants 4 4 3 5 5 6 5 4
Geometric Mean (Geometric Coefficient of Variation) [L/hr]
NA
(NA)
17013
(20.4)
15550
(27.4)
53420
(36.5)
123081
(53.5)
339062
(25.6)
452842
(47.5)
682543
(28.6)
14. Other Pre-specified Outcome
Title Number of Participants With Treatment-emergent Adverse Events (AEs) and 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 that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Cohort 1-8: Baseline up to Day 29; Cohort 9: Baseline up to Day 36; Cohort 10-12: Baseline up to Day 50

Outcome Measure Data

Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-9: Placebo Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg Cohort 10-12: Placebo
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively. Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
Measure Participants 7 6 6 7 6 6 6 6 6 18 9 9 13 9
AEs
2
28.6%
2
33.3%
5
83.3%
1
14.3%
2
33.3%
4
66.7%
5
83.3%
6
100%
3
50%
4
22.2%
5
55.6%
7
77.8%
8
61.5%
4
44.4%
SAEs
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%
0
0%
15. Other Pre-specified Outcome
Title Stage 1: Change From Baseline in Post-Prandial Area Under the Curve (AUC) of Glucose at Day 3 and 7
Description Area under the glucose concentration-time curve from 0 minute (approximately 20 minutes prior to the meal) to 180 minutes post initiation of meal.
Time Frame Baseline, Day 3 and 7

Outcome Measure Data

Analysis Population Description
Pharmacodynamic analysis population included all randomized participants who had received at least 1 dose of study medication and had PD data. Here, number analyzed signifies those participants who were evaluable at specified time points.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-8: Combined Placebo Cohort 9: Placebo
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7. Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
Measure Participants 7 6 6 7 6 6 6 6 6 16 2
Change at Day 3
1.44
(102)
44.9
(76.8)
-92.3
(78.2)
-54.0
(60.0)
46.7
(70.9)
-74.5
(59.7)
-140
(124)
-80.1
(70.6)
-10.6
(95.3)
Change at Day 7
-38.8
(95.5)
29.3
(161)
-147
(93.4)
-23.0
(125)
65.1
(85.1)
-39.6
(52.6)
-108
(139)
-38.4
(66.7)
-119
(81.7)
-9.04
(119)
-46.1
(6.98)
16. Other Pre-specified Outcome
Title Stage 1: Change From Baseline in 7-point Weighted Mean Glucose at Day 3 and Day 7
Description It was assessed by 7-point glucose measurements via the glucose oxidase method.
Time Frame Baseline, Day 3 and 7

Outcome Measure Data

Analysis Population Description
Pharmacodynamic analysis population included all randomized participants who had received at least 1 dose of study medication and had PD data.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-8: Combined Placebo Cohort 9: Placebo
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7. Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
Measure Participants 7 6 6 7 6 6 6 6 6 16 2
Change at Day 3
3.27
(24.1)
-0.0252
(16.3)
-17.9
(21.7)
1.04
(18.2)
20.2
(18.4)
-15.7
(12.4)
-31.7
(30.5)
-26.4
(22.9)
-23.9
(10.6)
0.506
(25.0)
-16.6
(12.0)
Change at Day 7
-15.6
(23.0)
7.44
(42.1)
-28.7
(26.9)
-8.45
(33.6)
7.05
(53.2)
-20.5
(10.2)
-33.9
(42.1)
-24.4
(29.4)
-12.8
(29.8)
-5.22
(25.9)
-23.0
(11.0)
17. Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Laboratory Abnormalities
Description Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit: less than (<) 0.8*lower limit of normal (LLN), platelet: <75 or greater than (>) 700*10^3/millimeter (mm)^3*upper limit of normal (ULN), leukocyte: <2.5 or >17.5*10^3/mm^3*ULN; total bilirubin 1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase: >3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN ;blood urea nitrogen, creatinine: >1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, calcium: <0.9*LLN or >1.1*ULN, albumin, total protein <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, creatine kinase >2.0*ULN; urine (red blood cell, white blood cell >6/high power field).
Time Frame Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50

Outcome Measure Data

Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-8: Combined Placebo Cohort 9: Placebo Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg Cohort 10-12: Placebo
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7. Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively. Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
Measure Participants 7 6 6 7 6 6 6 6 6 16 2 9 9 13 9
Count of Participants [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%
0
0%
0
0%
0
0%
18. Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Vital Signs
Description Criteria for vital signs: pulse rate <40 beats per minute (bpm), supine, sitting and erect pulse rate <40 bpm, supine pulse rate >120 bpm, sitting pulse rate >120 bpm, and erect pulse rate >120 bpm; systolic blood pressure: SBP <90 millimeters of mercury (mmHg), change from baseline in SBP greater than or equal to (>=) 30 mmHg; diastolic blood pressure: DBP <50 mmHg, change from baseline in DBP >=20 mmHg.
Time Frame Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50

Outcome Measure Data

Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-8: Combined Placebo Cohort 9: Placebo Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg Cohort 10-12: Placebo
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7. Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively. Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
Measure Participants 7 6 6 7 6 6 6 6 6 16 2 9 9 13 9
Count of Participants [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%
0
0%
0
0%
0
0%
19. Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Description Criteria for ECG findings: PR interval >=300 millisecond (msec), >=25 percent increase when baseline >200 msec, and >=50 percent increase when baseline less than or equal to (<=) 200 msec; QRS interval >=200 msec, >=25 percent increase when baseline >=100 msec, and >=50 percent increase when baseline <=100 msec; QT/QTc interval (corrected QT interval) >=500 msec.
Time Frame Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50

Outcome Measure Data

Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-8: Combined Placebo Cohort 9: Placebo Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg Cohort 10-12: Placebo
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7. Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively. Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
Measure Participants 7 6 6 7 6 6 6 6 6 16 2 9 9 13 9
Count of Participants [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%
0
0%
0
0%
0
0%
20. Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Physical Examinations
Description Full physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator.
Time Frame Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50

Outcome Measure Data

Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-8: Combined Placebo Cohort 9: Placebo Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg Cohort 10-12: Placebo
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7. Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively. Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
Measure Participants 7 6 6 7 6 6 6 6 6 16 2 9 9 13 9
Count of Participants [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%
0
0%
0
0%
0
0%
21. Other Pre-specified Outcome
Title Stage 1: Number of Participants With Hypoglycemia
Description Blood glucose level was checked for hypoglycemia by glucometer. Criteria for hypoglycemia: blood glucose level <60 mg/dL if accompanied by symptoms, blood glucose level <=50 mg/dL regardless of symptoms.
Time Frame Day 1: 0 hour (pre-dose) up to 48 hours post dose

Outcome Measure Data

Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-8: Combined Placebo Cohort 9: Placebo
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7. Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
Measure Participants 7 6 6 7 6 6 6 6 6 16 2
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
22. Other Pre-specified Outcome
Title Stage 1: Number of Participants With Clinically Significant Abnormal Rhythms
Description Criteria for abnormal rhythms: asymptomatic marked sinus bradycardia rate <35 bpm; asymptomatic supraventricular couplets, atrial bigeminy lasting >30 seconds; asymptomatic ventricular couplets, ventricular bigeminy lasting >30 seconds; asymptomatic type I second degree (wenckebach) atrioventricular block of >30 seconds duration; asymptomatic frequent premature ventricular complexes (=>200/24 hours); asymptomatic frequent premature atrial complexes (=>240/24 hours).
Time Frame Cohort 1- 8: Day 1 up to Day 3; Cohort 9: Day 1 up to Day 10

Outcome Measure Data

Analysis Population Description
Safety population will consist of all randomized patients who received at least 1 dose of study medication.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-8: Combined Placebo Cohort 9: Placebo
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7. Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
Measure Participants 7 6 6 7 6 6 6 6 6 16 2
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
23. Other Pre-specified Outcome
Title Stage 1: Number of Participants With Anti-Drug Antibodies
Description
Time Frame Day 0, 8, 14, 15, 21, 28 and 35

Outcome Measure Data

Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study medication. Here, number analyzed signifies those participants who were evaluable at specified time points.
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-8: Combined Placebo Cohort 9: Placebo
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7. Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
Measure Participants 7 6 6 7 6 6 6 6 6 16 2
Day 0
1
14.3%
2
33.3%
1
16.7%
3
42.9%
1
16.7%
1
16.7%
3
50%
2
33.3%
1
16.7%
1
5.6%
0
0%
Day 8
0
0%
2
33.3%
1
16.7%
2
28.6%
0
0%
1
16.7%
2
33.3%
2
33.3%
0
0%
1
5.6%
0
0%
Day 14
0
0%
2
33.3%
2
33.3%
2
28.6%
1
16.7%
1
16.7%
3
50%
2
33.3%
1
16.7%
Day 15
0
0%
0
0%
Day 21
0
0%
2
33.3%
1
16.7%
2
28.6%
1
16.7%
2
33.3%
4
66.7%
2
33.3%
1
16.7%
1
5.6%
0
0%
Day 28
0
0%
2
33.3%
1
16.7%
2
28.6%
1
16.7%
1
16.7%
4
66.7%
2
33.3%
1
16.7%
Day 35
0
0%
0
0%
24. Other Pre-specified Outcome
Title Stage 2: Number of Participants With Anti-Drug Antibodies
Description
Time Frame Day 0, 29 and 50

Outcome Measure Data

Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study medication. Here, number analyzed signifies those participants who were evaluable at specified time points.
Arm/Group Title Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg Cohort 10-12: Placebo
Arm/Group Description Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
Measure Participants 9 9 13 9
Day 0 (n= 9, 9, 13 ,9)
1
14.3%
1
16.7%
2
33.3%
0
0%
Day 29 (n= 9, 8, 7, 8)
0
0%
1
16.7%
2
33.3%
0
0%
Day 50 (n= 9, 8, 8, 8)
0
0%
3
50%
3
50%
0
0%

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-9: Placebo Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg Cohort 10-12: Placebo
Arm/Group Description Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1. Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1. Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8. Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively. Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22. Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
All Cause Mortality
Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-9: Placebo Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg Cohort 10-12: Placebo
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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-9: Placebo Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg Cohort 10-12: Placebo
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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Other (Not Including Serious) Adverse Events
Cohort 1: PF-04856883 0.1 Milligram (mg) Cohort 2: PF-04856883 0.3 mg Cohort 3: PF-04856883 1.0 mg Cohort 4: PF-04856883 3.0 mg Cohort 5: PF-04856883 6.0 mg Cohort 6: PF-04856883 12.0 mg Cohort 7: PF-04856883 24.0 mg Cohort 8: PF-04856883 36.0 mg Cohort 9: PF-04856883 18.0 mg Cohort 1-9: Placebo Cohort 10: PF-04856883 15.0 mg Cohort 11: PF-04856883 20.0 mg Cohort 12: PF-04856883 25.0 mg Cohort 10-12: Placebo
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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 2/7 (28.6%) 2/6 (33.3%) 5/6 (83.3%) 1/7 (14.3%) 2/6 (33.3%) 4/6 (66.7%) 5/6 (83.3%) 6/6 (100%) 3/6 (50%) 4/18 (22.2%) 5/9 (55.6%) 7/9 (77.8%) 8/13 (61.5%) 4/9 (44.4%)
Cardiac disorders
Tachycardia 0/7 (0%) 0/6 (0%) 0/6 (0%) 1/7 (14.3%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 1/13 (7.7%) 0/9 (0%)
Gastrointestinal disorders
Vomiting 0/7 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 1/6 (16.7%) 1/6 (16.7%) 2/6 (33.3%) 5/6 (83.3%) 1/6 (16.7%) 0/18 (0%) 2/9 (22.2%) 2/9 (22.2%) 7/13 (53.8%) 0/9 (0%)
Dyspepsia 0/7 (0%) 0/6 (0%) 0/6 (0%) 1/7 (14.3%) 0/6 (0%) 3/6 (50%) 0/6 (0%) 2/6 (33.3%) 0/6 (0%) 0/18 (0%) 1/9 (11.1%) 1/9 (11.1%) 3/13 (23.1%) 0/9 (0%)
Nausea 0/7 (0%) 0/6 (0%) 3/6 (50%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 2/6 (33.3%) 0/6 (0%) 0/18 (0%) 3/9 (33.3%) 1/9 (11.1%) 5/13 (38.5%) 0/9 (0%)
Diarrhea 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 1/6 (16.7%) 1/6 (16.7%) 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Constipation 0/7 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 1/6 (16.7%) 1/18 (5.6%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Abdominal pain upper 1/7 (14.3%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Abdominal discomfort 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 3/13 (23.1%) 0/9 (0%)
Abdominal pain 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Abdominal distension 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 3/9 (33.3%) 0/13 (0%) 0/9 (0%)
Stomach discomfort 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 3/13 (23.1%) 0/9 (0%)
Dysphagia 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 1/9 (11.1%) 0/13 (0%) 0/9 (0%)
Flatulence 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 1/13 (7.7%) 0/9 (0%)
Gastroesophageal reflux disease 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 1/13 (7.7%) 0/9 (0%)
Hematochezia 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 1/13 (7.7%) 0/9 (0%)
Hypoaesthesia oral 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 1/13 (7.7%) 0/9 (0%)
General disorders
Application site rash 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 2/6 (33.3%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Application site erythema 1/7 (14.3%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Application site pruritus 1/7 (14.3%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Asthenia 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/18 (0%) 1/9 (11.1%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Injection site rash 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Swelling 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Chest discomfort 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 1/13 (7.7%) 0/9 (0%)
Chills 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 1/13 (7.7%) 0/9 (0%)
Injection site erythema 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 1/9 (11.1%) 0/13 (0%) 0/9 (0%)
Injection site pruritus 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 1/13 (7.7%) 0/9 (0%)
Pyrexia 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 1/9 (11.1%) 0/13 (0%) 0/9 (0%)
Infections and infestations
Rhinitis 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Viral infection 0/7 (0%) 1/6 (16.7%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Upper respiratory tract infection 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/18 (5.6%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Otitis externa 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 1/9 (11.1%) 0/13 (0%) 0/9 (0%)
Tooth abscess 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 1/9 (11.1%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Urinary tract infection 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 1/13 (7.7%) 0/9 (0%)
Tinea infection 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 1/9 (11.1%)
Injury, poisoning and procedural complications
Excoriation 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 1/9 (11.1%)
Head injury 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Joint injury 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Metabolism and nutrition disorders
Anorexia 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 1/9 (11.1%) 3/9 (33.3%) 2/13 (15.4%) 0/9 (0%)
Musculoskeletal and connective tissue disorders
Back pain 0/7 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Muscle twitching 0/7 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Musculoskeletal stiffness 0/7 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Pain in extremity 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Muscle spasms 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/18 (5.6%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Nervous system disorders
Headache 1/7 (14.3%) 1/6 (16.7%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 1/6 (16.7%) 0/18 (0%) 1/9 (11.1%) 3/9 (33.3%) 6/13 (46.2%) 1/9 (11.1%)
Dizziness 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 1/9 (11.1%) 1/9 (11.1%) 1/13 (7.7%) 2/9 (22.2%)
Dysgeusia 0/7 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Paraesthesia 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 1/13 (7.7%) 0/9 (0%)
Somnolence 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 1/13 (7.7%) 0/9 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 0/7 (0%) 1/6 (16.7%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/18 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/13 (0%) 0/9 (0%)
Pharyngeal hypoaesthesia 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Productive cough 0/7 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Throat irritation 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/18 (5.6%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Skin and subcutaneous tissue disorders
Rash 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 1/18 (5.6%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Urticaria 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 1/9 (11.1%) 0/13 (0%) 0/9 (0%)
Milia 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/18 (5.6%) 0/9 (0%) 0/9 (0%) 0/13 (0%) 0/9 (0%)
Pruritus 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 0/9 (0%) 1/13 (7.7%) 0/9 (0%)
Pruritus generalised 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 1/9 (11.1%) 0/13 (0%) 0/9 (0%)
Vascular disorders
Hot flush 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/18 (0%) 0/9 (0%) 1/9 (11.1%) 0/13 (0%) 0/9 (0%)

Limitations/Caveats

[Not Specified]

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 Call Center
Organization Pfizer, Inc.
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00886821
Other Study ID Numbers:
  • B1111001
  • CVX-096-101
First Posted:
Apr 23, 2009
Last Update Posted:
Apr 18, 2017
Last Verified:
Mar 1, 2017