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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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10 mg/kg cohort

Group Type EXPERIMENTAL

CP-751,871

Intervention Type BIOLOGICAL

single dose, 1-hr IV infusion

20 mg/kg cohort

Group Type EXPERIMENTAL

CP-751,871

Intervention Type BIOLOGICAL

single dose, 1-hr IV infusion

20/20 mg/kg cohort

Group Type EXPERIMENTAL

CP-751,871, moxifloxacin, saline

Intervention Type BIOLOGICAL

Two doses at 20 mg/kg each on two consecutive days, each administered via 1-hr IV infusion

Interventions

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CP-751,871

single dose, 1-hr IV infusion

Intervention Type BIOLOGICAL

CP-751,871

single dose, 1-hr IV infusion

Intervention Type BIOLOGICAL

CP-751,871, moxifloxacin, saline

Two doses at 20 mg/kg each on two consecutive days, each administered via 1-hr IV infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes