A Pharmacokinetic And QT Study Of CP-751,871 In Healthy Subjects

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00926263
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 3
• Duration (Months): 10
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

This study is primarily to evaluate the single dose pharmacokinetics of CP-751,871 and its effect on QT interval prolongation.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Biological: CP-751,871; Biological: CP-751,871; Biological: CP-751,871, moxifloxacin, saline	Phase 1

Detailed Description

This study was terminated on October 30th, 2009. While the study was terminated due to adverse events and altered benefit/risk ratio in healthy subjects, the findings in healthy volunteers are not considered to alter the benefit/risk evaluation of figitumumab in cancer patients. No changes due to the termination of this study are anticipated in the conduct of the ongoing cancer patient studies with figitumumab at this time.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Open Label Study To Evaluate The Pharmacokinetics, Pharmacodynamics, And Effect On QT/QTc Interval For CP-751,871 Following Single Intravenous Administration To Healthy Adult Subjects
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 10 mg/kg cohort	Biological: CP-751,871; single dose, 1-hr IV infusion
Experimental: 20 mg/kg cohort	Biological: CP-751,871; single dose, 1-hr IV infusion
Experimental: 20/20 mg/kg cohort	Biological: CP-751,871, moxifloxacin, saline; Two doses at 20 mg/kg each on two consecutive days, each administered via 1-hr IV infusion

Outcome Measures

Primary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) [Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85]

2. Area Under the Curve From Time Zero to the Last Time Point With Quantifiable Concentration (AUClast) [Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85]

   Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

3. Plasma Clearance (CL) [Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85]

   Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

4. Apparent Volume of Distribution (Vz) [Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85]

   Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

5. Plasma Decay Half-Life (t1/2) [Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85]

   Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

6. QTc Using Fridericia's Correction Method (QTcF) After Receiving CP-751,871 at the 20/20 mg/kg Dose Level [Day 1 at 1 and 24 hours post-dose, Day 7, 28]

   QTcF is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate using Fridericia's correction

Secondary Outcome Measures

1. QTcF After Receiving Moxifloxacin at the Historical Moxifloxacin Median Tmax of 3 Hours [baseline, 3 hours postdose]

2. Serum Concentration of Insulin-like Growth Factor 1 (IGF-1) [Day 1 pre-dose (Baseline), 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85]

   IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.

3. Serum Concentration of Free Insulin-like Growth Factor 1 (IGF-1) [Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85]

   IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.

4. Serum Concentration of Insulin-like Growth Factor 2 (IGF-2) [Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85]

   IGF-2 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.

5. Serum Concentration of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) [Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85]

   IGFBP-3 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.

6. Serum Concentration of Insulin [Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85]

   Insulin is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.

7. Serum Concentration of Fasting Glucose [Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85]

   Glucose is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.

8. Anti-drug Antibodies (ADA) Against CP-751,871 in Serum Samples [Day 1 pre-dose, Day 15, 29, 57, 85]

   Number of participants who tested positive for ADA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male subjects and/or healthy female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

• 12-lead ECG demonstrating QTc >450 msec at screening or other clinically significant abnormalities at screening.

• History or family history of risk factors for QTc interval prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, myocardial ischemia or infarction); family history of sudden death.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Haven	Connecticut	United States	06511-5473

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00926263
• Other Study ID Numbers: A4021037
• First Posted: Jun 23, 2009
• Last Update Posted: May 7, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Pfizer: Pharmacokinetics; Pharmacodynamics; QTc interval prolongation
• Additional relevant MeSH terms: Moxifloxacin; Antibodies, Monoclonal

Study Results

Participant Flow

Pre-assignment Detail	Study participants were planned to be assigned to 1 of 3 sequential dosing cohorts: CP-751,871 at 10 mg/kg; at 20 mg/kg; 2 doses of 20 mg/kg on consecutive days. Dosing was via intravenous (IV) administration. The third dosing cohort (2 doses of 20 mg/kg on consecutive days) did not enroll participants due to early termination of the study.

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Period Title: Overall Study
STARTED	16	12
COMPLETED	16	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg	Total
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	Total of all reporting groups
Overall Participants	16	12	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.9 (6.3)	30.3 (7.7)	30.6 (6.8)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	16 100%	12 100%	28 100%
Race/Ethnicity, Customized (participants) [Number]
White	4 25%	3 25%	7 25%
Black	10 62.5%	8 66.7%	18 64.3%
Asian	0 0%	1 8.3%	1 3.6%
Other	2 12.5%	0 0%	2 7.1%

Outcome Measures

1. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax)
Time Frame	Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Measure Participants	16	12
Mean (Standard Deviation) [mg/L]	225.1 (54.175)	420.6 (62.175)

2. Primary Outcome

Title	Area Under the Curve From Time Zero to the Last Time Point With Quantifiable Concentration (AUClast)
Description	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame	Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Measure Participants	16	12
Mean (Standard Deviation) [mg*h/L]	80740 (14184)	184000 (27811)

3. Primary Outcome

Title	Plasma Clearance (CL)
Description	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time Frame	Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85

Outcome Measure Data

Analysis Population Description

All treated and evaluable participants (had measurements related to the PK parameter stated above).

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Measure Participants	13	12
Mean (Standard Deviation) [mL/day/kg]	2.808 (0.3804)	2.353 (0.4346)

4. Primary Outcome

Title	Apparent Volume of Distribution (Vz)
Description	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Time Frame	Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85

Outcome Measure Data

Analysis Population Description

All treated and evaluable participants (had measurements related to the PK parameter stated above).

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Measure Participants	13	12
Mean (Standard Deviation) [mL/kg]	84.89 (13.731)	92.17 (14.978)

5. Primary Outcome

Title	Plasma Decay Half-Life (t1/2)
Description	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame	Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85

Outcome Measure Data

Analysis Population Description

All treated and evaluable participants (had measurements related to the PK parameter stated above).

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Measure Participants	13	12
Mean (Standard Deviation) [days]	21.08 (2.9950)	27.75 (5.7969)

6. Primary Outcome

Title	QTc Using Fridericia's Correction Method (QTcF) After Receiving CP-751,871 at the 20/20 mg/kg Dose Level
Description	QTcF is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate using Fridericia's correction
Time Frame	Day 1 at 1 and 24 hours post-dose, Day 7, 28

Outcome Measure Data

Analysis Population Description

Data not obtained due to early termination of the study.

Arm/Group Title	CP-751,871 20/20 mg/kg
Arm/Group Description	Participants not enrolled due to early termination of the study.
Measure Participants	0

7. Secondary Outcome

Title	QTcF After Receiving Moxifloxacin at the Historical Moxifloxacin Median Tmax of 3 Hours
Time Frame	baseline, 3 hours postdose

Outcome Measure Data

Analysis Population Description

Data not obtained due to early termination of the study.

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Measure Participants	0	0

8. Secondary Outcome

Title	Serum Concentration of Insulin-like Growth Factor 1 (IGF-1)
Description	IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.
Time Frame	Day 1 pre-dose (Baseline), 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85

Outcome Measure Data

Analysis Population Description

All treated participants who had at least 1 postdose concentration measurement.

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Measure Participants	16	12
Baseline	138 (33)	128 (23)
at Cmax	566 (142)	610 (143)

9. Secondary Outcome

Title	Serum Concentration of Free Insulin-like Growth Factor 1 (IGF-1)
Description	IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.
Time Frame	Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85

Outcome Measure Data

Analysis Population Description

All treated participants who had at least 1 postdose concentration measurement.

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Measure Participants	16	12
Baseline	17.2 (6.6)	13.9 (5.6)
at Cmax	143 (45)	168 (43)

10. Secondary Outcome

Title	Serum Concentration of Insulin-like Growth Factor 2 (IGF-2)
Description	IGF-2 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.
Time Frame	Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85

Outcome Measure Data

Analysis Population Description

All treated participants who had at least 1 postdose concentration measurement.

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Measure Participants	16	12
Baseline	1550 (440)	1476 (229)
at Cmax	2039 (582)	1909 (275)

11. Secondary Outcome

Title	Serum Concentration of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)
Description	IGFBP-3 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.
Time Frame	Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85

Outcome Measure Data

Analysis Population Description

All treated participants who had at least 1 postdose concentration measurement.

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Measure Participants	16	12
Baseline	2041 (546)	1978 (496)
at Cmax	4945 (1035)	5819 (1310)

12. Secondary Outcome

Title	Serum Concentration of Insulin
Description	Insulin is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.
Time Frame	Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85

Outcome Measure Data

Analysis Population Description

All treated participants who had at least 1 postdose concentration measurement.

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Measure Participants	16	12
Baseline	5.13 (3.17)	4.07 (3.30)
at Cmax	37.6 (23.8)	40.0 (34.5)

13. Secondary Outcome

Title	Serum Concentration of Fasting Glucose
Description	Glucose is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.
Time Frame	Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85

Outcome Measure Data

Analysis Population Description

All treated participants who had at least 1 postdose concentration measurement.

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Measure Participants	16	12
Baseline	87.7 (6.4)	87.3 (5.1)
at Cmax	104 (21)	101 (16)

14. Secondary Outcome

Title	Anti-drug Antibodies (ADA) Against CP-751,871 in Serum Samples
Description	Number of participants who tested positive for ADA
Time Frame	Day 1 pre-dose, Day 15, 29, 57, 85

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	CP-751,871 10 mg/kg	CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.	A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
Measure Participants	16	12
Nominal Day 1	0 0%	0 0%
Nominal Day 15	0 0%	0 0%
Nominal Day 29	0 0%	0 0%
Nominal Day 57	0 0%	0 0%
Nominal Day 85	0 0%	0 0%

Adverse Events

Arm/Group Title	CP-751,871 10 mg/kg		CP-751,871 20 mg/kg
Arm/Group Description	A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.		A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
All Cause Mortality
	CP-751,871 10 mg/kg		CP-751,871 20 mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CP-751,871 10 mg/kg		CP-751,871 20 mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	CP-751,871 10 mg/kg		CP-751,871 20 mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/16 (56.3%)		12/12 (100%)
Blood and lymphatic system disorders
Lymphadenitis	0/16 (0%)		1/12 (8.3%)
Ear and labyrinth disorders
Cerumen impaction	1/16 (6.3%)		0/12 (0%)
Ear discomfort	0/16 (0%)		1/12 (8.3%)
Hypoacusis	0/16 (0%)		1/12 (8.3%)
Tinnitus	3/16 (18.8%)		0/12 (0%)
Eye disorders
Conjunctivitis allergic	0/16 (0%)		1/12 (8.3%)
Dry eye	0/16 (0%)		9/12 (75%)
Keratoconjunctivitis sicca	0/16 (0%)		1/12 (8.3%)
Ocular hyperaemia	0/16 (0%)		9/12 (75%)
Vision blurred	1/16 (6.3%)		0/12 (0%)
Gastrointestinal disorders
Abdominal discomfort	0/16 (0%)		1/12 (8.3%)
Abdominal pain	0/16 (0%)		1/12 (8.3%)
Diarrhoea	2/16 (12.5%)		1/12 (8.3%)
Dyspepsia	0/16 (0%)		1/12 (8.3%)
Gingival pain	0/16 (0%)		1/12 (8.3%)
Hyperchlorhydria	0/16 (0%)		1/12 (8.3%)
Nausea	2/16 (12.5%)		1/12 (8.3%)
Vomiting	0/16 (0%)		2/12 (16.7%)
General disorders
Asthenia	0/16 (0%)		1/12 (8.3%)
Chest discomfort	0/16 (0%)		1/12 (8.3%)
Chest pain	1/16 (6.3%)		0/12 (0%)
Fatigue	1/16 (6.3%)		3/12 (25%)
Pyrexia	0/16 (0%)		1/12 (8.3%)
Infections and infestations
Bronchitis	1/16 (6.3%)		0/12 (0%)
Chlamydial infection	0/16 (0%)		1/12 (8.3%)
Gastroenteritis	0/16 (0%)		2/12 (16.7%)
Nasopharyngitis	0/16 (0%)		1/12 (8.3%)
Periorbital cellulitis	1/16 (6.3%)		0/12 (0%)
Respiratory tract infection viral	0/16 (0%)		1/12 (8.3%)
Viral upper respiratory tract infection	0/16 (0%)		1/12 (8.3%)
Injury, poisoning and procedural complications
Head injury	1/16 (6.3%)		0/12 (0%)
Multiple injuries	1/16 (6.3%)		0/12 (0%)
Road traffic accident	0/16 (0%)		1/12 (8.3%)
Thermal burn	1/16 (6.3%)		0/12 (0%)
Investigations
Audiogram abnormal	2/16 (12.5%)		0/12 (0%)
Echocardiogram abnormal	1/16 (6.3%)		0/12 (0%)
Heart rate irregular	1/16 (6.3%)		0/12 (0%)
Schirmer's test abnormal	1/16 (6.3%)		0/12 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/16 (0%)		1/12 (8.3%)
Muscle twitching	0/16 (0%)		2/12 (16.7%)
Musculoskeletal chest pain	0/16 (0%)		2/12 (16.7%)
Myalgia	1/16 (6.3%)		0/12 (0%)
Neck pain	0/16 (0%)		1/12 (8.3%)
Nervous system disorders
Dizziness	2/16 (12.5%)		0/12 (0%)
Headache	3/16 (18.8%)		3/12 (25%)
Paraesthesia	1/16 (6.3%)		0/12 (0%)
Somnolence	2/16 (12.5%)		1/12 (8.3%)
Respiratory, thoracic and mediastinal disorders
Cough	1/16 (6.3%)		0/12 (0%)
Dry throat	0/16 (0%)		2/12 (16.7%)
Dysphonia	0/16 (0%)		1/12 (8.3%)
Rhinitis allergic	0/16 (0%)		1/12 (8.3%)
Rhinorrhoea	0/16 (0%)		1/12 (8.3%)
Skin and subcutaneous tissue disorders
Hair growth abnormal	1/16 (6.3%)		0/12 (0%)
Nail discolouration	1/16 (6.3%)		0/12 (0%)

Limitations/Caveats

This study was terminated prior to enrollment of participants into Cohort 3 (2 doses of 20 mg/kg on consecutive days). Therefore, endpoints relating to that cohort were not assessed.

More Information

Certain Agreements

All Principal Investigators ARE 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.