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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: PH-797804

• Registration Number: NCT01479647
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-24
• Study Start: 2011-12
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-25
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PH-797804 1 mg Fasted	PH-797804	Subjects will receive a single 1 mg dose in the fasted state
PH-797804 1 mg Fed	PH-797804	Subjects will receive a single 1 mg dose following a high-fat meal
PH-797804 10 mg Fasted	PH-797804	Subjects will receive a single 10 mg dose in the fasted state
PH-797804 10 mg Fed	PH-797804	Subjects will receive a single 10 mg dose following a high-fat meal
PH-797804 24 mg Fed	PH-797804	Subjects will receive a single 24 mg dose following a high-fat meal

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: peak plasma concentration	0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose
Pharmacokinetics: time to peak plasma concentration	0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose
Pharmacokinetics: area under the plasma concentration-time curve	0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose
Pharmacokinetics: terminal plasma half-life	0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore