AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects

August 15, 2014 updated by: Pfizer

A Phase 1, Open Label, Single Dose 3 Way Crossover Study to Evaluate the Bioavailability of a Solid Dose Formulation of PF 04965842 Relative to a Suspension Formulation Under Fasting Conditions and the Effect of Food on the Bioavailability of the Solid Dosage Formulation of Pf 04965842 in Healthy Subjects

Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a solid dose formulation of PF 04965842 relative to a suspension formulation under fasting conditions and the effect of food on the bioavailability of the solid dosage formulation of PF 04965842 in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1070
        • Pfizer Investigational Site

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male subjects and female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Subjects who received within 7 days prior to the first dose of study medication or are likely to receive during the study any moderate strong inhibitors of CYP3A4, eg, itraconazole, erythromycin, ketoconazole, protease inhibitors, verapamil, or diltiazem.
  • Subjects who received within 28 days or are likely to receive during the study inducers of CYP3A4, eg rifampin.

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: Treatment B
Drug: PF-04965842
Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions
Drug: PF-04965842
Subjects will receive 400 mg PF 04965842 oral suspension under fasted conditions
Experimental: Treatment C
Drug: PF- 04965842
Subjects will receive 4 x 100 mg PF 04965842 tablet under fed conditions
Experimental: Treatment A
Drug: PF-04965842
Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions
Drug: PF-04965842
Subjects will receive 400 mg PF 04965842 oral suspension under fasted conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve from Time Zero to infinity (AUC inf)
Time Frame: 15 days
15 days
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 15 days
15 days
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: 15 days
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 15 days
15 days
Plasma Decay Half-Life (t1/2)
Time Frame: 15 days
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
15 days

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.

General Publications

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

June 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (Estimate)

June 13, 2014

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 15, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7451004

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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