Relative Bioavailability and Food Effect Study

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00827515

First received: January 21, 2009

Last updated: May 18, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

January 21, 2009

Last Updated Date

May 18, 2009

Start Date ^ICMJE

February 2009

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Blood levels of PH797804 up to 336 hours after dosing in each treatment period [ Time Frame: 336 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00827515 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety and tolerability of PH797804 in each treatment period up to 336 hours post-dose [ Time Frame: 336 hours ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Relative Bioavailability and Food Effect Study

Official Title ^ICMJE

A Phase 1, Randomized, Open-Label, Single Dose, 4-Way Crossover Study In Healthy Volunteers To Assess The Relative Bioavailability Of The Oral Powder In Capsule (PIC) And An Immediate Release (IR) Film-Coated Tablet Of PH-797804 In The Fed And Fasted State

Brief Summary

Initial studies have used a powder in capsule formulation of PH797804. In future studies an immediate release tablet will be used. The purpose of this study is to compare blood levels of PH797804 following an oral dose of the powder in capsule formulation and the tablet formulation. In addition the effect of food blood levels of PH797804 will be investigated

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

Pain

Intervention ^ICMJE

Drug: PH797804
Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fasted state
Drug: PH797804
Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fed state
Drug: PH797804
Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fasted state
Drug: PH797804
Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fed state

Study Arm (s)

Experimental: One
Intervention: Drug: PH797804
Experimental: Two
Intervention: Drug: PH797804
Experimental: Three
Intervention: Drug: PH797804
Experimental: Four
Intervention: Drug: PH797804

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

Withdrawn

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2009

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy male or female subjects aged 21 to 55 years
Healthy is defined as no clinical relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests
Willing to use acceptable methods of contraception as outlined in the study protocol
Body mass index between 18 to 30 kg/m2
Subjects who are willing and able to comply with the scheduled visits, treatment plan and other study procedures

Exclusion Criteria:

Subjects with evidence or history of clinically significant disease
Pregnant or nursing females
Females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to the first dose until day 15 of period 4
Subjects with conditions possibly affecting drug absorption (eg gastrectomy)
A positive approved immunoassay/ELISA blood test for TB
Subjects with a history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men
Subjects who have use prescription or nonprescription drugs, vitamins and/or dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
Subjects who have been administered medications capable of inducing hepatic enzyme metabolism (eg barbiturates, rifampin, carbamazepine, phenytoin or primidone) within 14 days (or 5 half-lives of the inducing agent, whichever is longer) of day 1 or within 28 days of administration of St John's wort

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

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00827515

Other Study ID Numbers ^ICMJE

A6631025

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2009

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

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