Relative Bioavailability and Food Effect Study

March 4, 2015 updated by: Pfizer

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One
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
Experimental: Two
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
Experimental: Three
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
Experimental: Four
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood levels of PH797804 up to 336 hours after dosing in each treatment period
Time Frame: 336 hours
336 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of PH797804 in each treatment period up to 336 hours post-dose
Time Frame: 336 hours
336 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

April 1, 2009

Study Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

January 21, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (Estimate)

January 22, 2009

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A6631025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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