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

A Phase 1, Randomized, Open-Label, Single Dose, 2-Cohort Crossover Study To Determine The Effect Of Food On The Pharmacokinetics Of Orally Administered PH-797804 In Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: PH-797804; Drug: PH-797804; Drug: PH-797804

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 188770
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PH-797804 1 mg Fasted; Subjects will receive a single 1 mg dose in the fasted state	Drug: PH-797804; Tablet, 1 mg, single dose; Drug: PH-797804; Tablet, 10 mg, single dose; Drug: PH-797804; Tablet, 24 mg, single dose
Experimental: PH-797804 1 mg Fed; Subjects will receive a single 1 mg dose following a high-fat meal	Drug: PH-797804; Tablet, 1 mg, single dose; Drug: PH-797804; Tablet, 10 mg, single dose; Drug: PH-797804; Tablet, 24 mg, single dose
Experimental: PH-797804 10 mg Fasted; Subjects will receive a single 10 mg dose in the fasted state	Drug: PH-797804; Tablet, 1 mg, single dose; Drug: PH-797804; Tablet, 10 mg, single dose; Drug: PH-797804; Tablet, 24 mg, single dose
Experimental: PH-797804 10 mg Fed; Subjects will receive a single 10 mg dose following a high-fat meal	Drug: PH-797804; Tablet, 1 mg, single dose; Drug: PH-797804; Tablet, 10 mg, single dose; Drug: PH-797804; Tablet, 24 mg, single dose
Experimental: PH-797804 24 mg Fed; Subjects will receive a single 24 mg dose following a high-fat meal	Drug: PH-797804; Tablet, 1 mg, single dose; Drug: PH-797804; Tablet, 10 mg, single dose; Drug: PH-797804; Tablet, 24 mg, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: November 22, 2011
• First Posted (Estimate): November 24, 2011

Study Record Updates

• Last Update Posted (Estimate): February 28, 2012
• Last Update Submitted That Met QC Criteria: February 25, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: A6631034