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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PH-797804

Study type: Interventional

Funder types: Industry

Identifiers

NCT01479647

A6631034

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 5 patient groups

PH-797804 1 mg Fasted

Experimental group

Description:

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

Treatment:

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

PH-797804 1 mg Fed

Experimental group

Description:

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

Treatment:

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

PH-797804 10 mg Fasted

Experimental group

Description:

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

Treatment:

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

PH-797804 10 mg Fed

Experimental group

Description:

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

Treatment:

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

PH-797804 24 mg Fed

Experimental group

Description:

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

Treatment:

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804