Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-11-30

Brief Summary

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The purpose is to study the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single IV Dose 1

Group Type EXPERIMENTAL

PF-04427429

Intervention Type DRUG

single intravenous infusion of 10 mg PF-04427429 or placebo

Single IV Dose 2

Group Type EXPERIMENTAL

PF-04427429

Intervention Type DRUG

single intravenous infusion of 30 mg PF-04427429 or placebo

Single IV Dose 3

Group Type EXPERIMENTAL

PF-04427429

Intervention Type DRUG

single intravenous infusion of 100 mg PF-04427429 or placebo

Single IV Dose 4

Group Type EXPERIMENTAL

PF-04427429

Intervention Type DRUG

single intravenous infusion of 300 mg PF-04427429 or placebo

Single IV Dose 5

Group Type EXPERIMENTAL

PF-04427429

Intervention Type DRUG

single intravenous infusion of 1000 mg PF-04427429 or placebo

Interventions

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PF-04427429

single intravenous infusion of 10 mg PF-04427429 or placebo

Intervention Type DRUG

PF-04427429

single intravenous infusion of 30 mg PF-04427429 or placebo

Intervention Type DRUG

PF-04427429

single intravenous infusion of 100 mg PF-04427429 or placebo

Intervention Type DRUG

PF-04427429

single intravenous infusion of 300 mg PF-04427429 or placebo

Intervention Type DRUG

PF-04427429

single intravenous infusion of 1000 mg PF-04427429 or placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects between the ages of 18 and 50 years inclusive (unless local regulations dictate a minimum age of 21 years). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of between 50 kg and 100 kg inclusive.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption.
* 12-lead ECG demonstrating QTcF \>450 msec at Screening. If QTcF exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes