Food Effect Study for PF-06372865

October 24, 2014 updated by: Pfizer

A Phase 1, Cross-over, Randomized, Single-dose Open Label Study To Determine The Effect Of Food On The Pharmacokinetics Of Orally Administered Pf-06372865 In Healthy Adult Subjects

This study has been designed to investigate the effect of high fat food on the pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.

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 Clinical Research Unit

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 and/or 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:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Screening supine blood pressure > 140 mm Hg (systolic) or >90 mm Hg (diastolic), following at least 5 minutes of supine rest.
  • Any condition possibly affecting drug absorption: current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecysectomy) which would be expected to influence the absorption of drugs.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: fasted condition
Drug: PF-06372865
7.5 mg as 3 x 2.5 mg tablets single dose
OTHER: fed condition
Drug: PF-06372865
7.5 mg as 3 x 2.5 mg tablets single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time Frame: basline to 48 hours
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
basline to 48 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: basline to 48 hours
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
basline to 48 hours
Maximum Observed Plasma Concentration (Cmax)
Time Frame: basline to 48 hours
basline to 48 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: basline to 48 hours
basline to 48 hours
Plasma Decay Half-Life (t1/2)
Time Frame: basline to 48 hours
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
basline to 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Systolic Blood Pressure
Time Frame: basline to 48 hours
Value at time T minus value at baseline.
basline to 48 hours
Change from Baseline in Diastolic Blood Pressure
Time Frame: basline to 48 hours
Value at time T minus value at baseline.
basline to 48 hours
Change from baseline in heart rate
Time Frame: basline to 48 hours
value at time T minus value at baseline
basline to 48 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

September 1, 2014

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 13, 2014

First Posted (ESTIMATE)

August 15, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 24, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7431008
  • 2014-002967-13 (EUDRACT_NUMBER)

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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