A Study To Compare The Pharmacokinetics Of Different Formulations Of PF-04937319 In Healthy Subjects

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01513928

First received: January 17, 2012

Last updated: March 8, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 17, 2012

Last Updated Date

March 8, 2012

Start Date ^ICMJE

January 2012

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Pf-04937319: Maximum plasma concentration (Cmax) [ Time Frame: 0 - 96 hours post dose ] [ Designated as safety issue: No ]
Pf-04937319: Time for Cmax (Tmax) [ Time Frame: 0 - 96 hours post dose ] [ Designated as safety issue: No ]
Pf-04937319: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) [ Time Frame: 0 - 96 hours post dose ] [ Designated as safety issue: No ]
Pf-04937319: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) [ Time Frame: 0 - 96 hours post dose ] [ Designated as safety issue: No ]
Pf-04937319: terminal half-life (T1/2) [ Time Frame: 0 - 96 hours post dose ] [ Designated as safety issue: No ]
PF-06455349: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 - 96 hours post dose ] [ Designated as safety issue: No ]
PF-06455349: Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 - 96 hours post dose ] [ Designated as safety issue: No ]
PF-06455349: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0 - 96 hours post dose ] [ Designated as safety issue: No ]
PF-06455349: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0 - 96 hours post dose ] [ Designated as safety issue: No ]
PF-06455349: Plasma Decay Half-Life (t1/2) [ Time Frame: 0 - 96 hours post dose ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01513928 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 Compare The Pharmacokinetics Of Different Formulations Of PF-04937319 In Healthy Subjects

Official Title ^ICMJE

A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-04937319 In Overweight And Obese Otherwise Healthy Subjects

Brief Summary

This study is designed to compare the pharmacokinetics of three different formulations of Pf-04937319

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Pf-04937319
Formulation A) Pf-04937319 50 mg - administered as tablet
Drug: Pf-04937319
Formulation B) Pf-04937319 50 mg - administered as capsule
Drug: Pf-04937319
Formulation C) Pf-04937319 50 mg - administered as capsule

Study Arm (s)

Not Provided

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 and/or female subjects 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 measurement, 12-lead ECG or clinical laboratory tests.
Subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of treatment.
Body Mass Index (BMI) of 23 to 33 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 (excluding untreated seasonal allergies).
Any condition possibly affecting drug absorption (eg, gastrectomy).
A positive urine drug screen.

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

NCT01513928

Other Study ID Numbers ^ICMJE

B1621005

Has Data Monitoring Committee

Yes

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

March 2012

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

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