A Healthy Volunteer Study To Assess Relative Bioavailability Of Powder-In-Capsule And A Tablet Formulation And The Effect Of Food On The Pharmacokinetics Of The Tablet Formulation

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

2013-03-31

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this study in healthy volunteers is to assess the relative bioavailability of PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the pharmacokinetics of the tablet formulation.

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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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PF-05175157 PIC in fed state

200 mg single dose of PF-05175157 administered as PIC in the fed state (following a standard high fat meal).

Group Type EXPERIMENTAL

PF-05175157

Intervention Type DRUG

Single 200 mg dose of PF-05175157 administered as powder in capsule (2x100 mg)

PF-05175157 tablet in fed state

200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal).

Group Type EXPERIMENTAL

PF-05175157

Intervention Type DRUG

Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)

PF-05175157 tablet in fed state (repeat)

200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal).

Group Type EXPERIMENTAL

PF-05175157

Intervention Type DRUG

Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)

PF-05175157 tablet in fasted state

200 mg single dose of PF-05175157 administered as tablet formulation in the fasted state (following at least a 10 hour fast).

Group Type EXPERIMENTAL

PF-05175157

Intervention Type DRUG

Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)

Interventions

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PF-05175157

Single 200 mg dose of PF-05175157 administered as powder in capsule (2x100 mg)

Intervention Type DRUG

PF-05175157

Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)

Intervention Type DRUG

PF-05175157

Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)

Intervention Type DRUG

PF-05175157

Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
* Women must be of non childbearing potential
* Body Mass Index (BMI) of 25 to 35 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms, optic nerve disease or retinal disease.
* History of habitual smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day 0

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes