AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-08-31

Brief Summary

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Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a solid dose formulation of PF 04965842 relative to a suspension formulation under fasting conditions and the effect of food on the bioavailability of the solid dosage formulation of PF 04965842 in healthy subjects.

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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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Treatment A

Group Type EXPERIMENTAL

PF-04965842

Intervention Type DRUG

Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions

Treatment B

Group Type EXPERIMENTAL

PF-04965842

Intervention Type DRUG

Subjects will receive 400 mg PF 04965842 oral suspension under fasted conditions

Treatment C

Group Type EXPERIMENTAL

PF- 04965842

Intervention Type DRUG

Subjects will receive 4 x 100 mg PF 04965842 tablet under fed conditions

Interventions

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PF-04965842

Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions

Intervention Type DRUG

PF-04965842

Subjects will receive 400 mg PF 04965842 oral suspension under fasted conditions

Intervention Type DRUG

PF- 04965842

Subjects will receive 4 x 100 mg PF 04965842 tablet under fed conditions

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects and 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

* Subjects who received within 7 days prior to the first dose of study medication or are likely to receive during the study any moderate strong inhibitors of CYP3A4, eg, itraconazole, erythromycin, ketoconazole, protease inhibitors, verapamil, or diltiazem.
* Subjects who received within 28 days or are likely to receive during the study inducers of CYP3A4, eg rifampin.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes