A Study To Investigate The Effect Of Food On The Pharmacokinetics Of PH-797804

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-02-29

Brief Summary

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The purpose of this study is to investigate the effect of food on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.

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Detailed Description

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Conditions

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Healthy Volunteers

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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PH-797804 1 mg Fasted

Subjects will receive a single 1 mg dose in the fasted state

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 1 mg, single dose

PH-797804 1 mg Fed

Subjects will receive a single 1 mg dose following a high-fat meal

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 1 mg, single dose

PH-797804 10 mg Fasted

Subjects will receive a single 10 mg dose in the fasted state

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 10 mg, single dose

PH-797804 10 mg Fed

Subjects will receive a single 10 mg dose following a high-fat meal

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 10 mg, single dose

PH-797804 24 mg Fed

Subjects will receive a single 24 mg dose following a high-fat meal

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 24 mg, single dose

Interventions

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PH-797804

Tablet, 1 mg, single dose

Intervention Type DRUG

PH-797804

Tablet, 1 mg, single dose

Intervention Type DRUG

PH-797804

Tablet, 10 mg, single dose

Intervention Type DRUG

PH-797804

Tablet, 10 mg, single dose

Intervention Type DRUG

PH-797804

Tablet, 24 mg, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 21 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 measurements, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 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 disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week for males.

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes