Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion

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

2013-05-31

Study Completion Date

2013-06-30

Brief Summary

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This study aims to test plasma exposure to PF-05089771 with same formulation will be used for phase II trials (capsule).

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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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Oral disperion fasted

A single dose of 450 mg PF-05089771 TS oral dispersion in fasted conditions.

Group Type EXPERIMENTAL

PF-05089771

Intervention Type DRUG

450mg

Capsule fasted

single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fasted conditions

Group Type EXPERIMENTAL

PF-05089771

Intervention Type DRUG

450mg

Capsule fed

single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fed conditions

Group Type EXPERIMENTAL

PF-05089771

Intervention Type DRUG

450mg

Interventions

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PF-05089771

450mg

Intervention Type DRUG

PF-05089771

450mg

Intervention Type DRUG

PF-05089771

450mg

Intervention Type DRUG

Other Intervention Names

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no specified no specified no specified

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female 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). Females must be of non-childbearing potential.
* 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, indicating that the subject has been informed of all pertinent aspects of the trial.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria

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