Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-08-31

Brief Summary

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This study is designed to compare the pharmacokinetics of two different lots of tablets.

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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

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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formulation comparison

Group Type EXPERIMENTAL

Treatment A

Intervention Type DRUG

150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R3 lot

Treatment B

Intervention Type DRUG

150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R4 lot

Interventions

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Treatment A

150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R3 lot

Intervention Type DRUG

Treatment B

150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R4 lot

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female (non childbearing potential) subjects between the ages of 18 and 55 years, inclusive. 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. Women must be of non childbearing potential as defined in Lifestyle Guidelines.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement \[confirmed by a single repeat, if necessary\] following at least 5 minutes of rest.
* Any condition possibly affecting drug absorption (eg, gastrectomy).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes