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

NCT01479647 | Completed Phase 1

• 1 other identifier: A6631034
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (5)

PH-797804 1 mg Fasted

EXPERIMENTAL

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

Drug: PH-797804

PH-797804 1 mg Fed

EXPERIMENTAL

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

Drug: PH-797804

PH-797804 10 mg Fasted

EXPERIMENTAL

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

Drug: PH-797804

PH-797804 10 mg Fed

EXPERIMENTAL

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

Drug: PH-797804

PH-797804 24 mg Fed

EXPERIMENTAL

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

Drug: PH-797804

Interventions

PH-797804 DRUG

Tablet, 1 mg, single dose

PH-797804 1 mg Fasted

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

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

MeSH Terms

Interventions

PH 797804

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: December 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

SG (1)