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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01479647

First received: November 22, 2011

Last updated: February 25, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 22, 2011

Last Updated Date

February 25, 2012

Start Date ^ICMJE

December 2011

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacokinetics: peak plasma concentration [ Time Frame: 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose ] [ Designated as safety issue: No ]
Pharmacokinetics: time to peak plasma concentration [ Time Frame: 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose ] [ Designated as safety issue: No ]
Pharmacokinetics: area under the plasma concentration-time curve [ Time Frame: 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose ] [ Designated as safety issue: No ]
Pharmacokinetics: terminal plasma half-life [ Time Frame: 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Pharmacokinetics: peak plasma concentration [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Pharmacokinetics: time to peak plasma concentration [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Pharmacokinetics: area under the plasma concentration-time curve [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Pharmacokinetics: terminal plasma half-life [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01479647 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy Volunteers

Intervention ^ICMJE

Drug: PH-797804
Tablet, 1 mg, single dose
Drug: PH-797804
Tablet, 10 mg, single dose
Drug: PH-797804
Tablet, 24 mg, single dose

Study Arm (s)

Experimental: PH-797804 1 mg Fasted
Subjects will receive a single 1 mg dose in the fasted state

Intervention: Drug: PH-797804
Experimental: PH-797804 1 mg Fed
Subjects will receive a single 1 mg dose following a high-fat meal

Intervention: Drug: PH-797804
Experimental: PH-797804 10 mg Fasted
Subjects will receive a single 10 mg dose in the fasted state

Intervention: Drug: PH-797804
Experimental: PH-797804 10 mg Fed
Subjects will receive a single 10 mg dose following a high-fat meal

Intervention: Drug: PH-797804
Experimental: PH-797804 24 mg Fed
Subjects will receive a single 24 mg dose following a high-fat meal

Intervention: Drug: PH-797804

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2012

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

21 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Singapore

Administrative Information

NCT Number ^ICMJE

NCT01479647

Other Study ID Numbers ^ICMJE

A6631034

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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