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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01513928

Enrollment

Registered

2012-01-20

Start date

2012-01-31

Completion date

2012-02-29

Last updated

2012-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

pharmacokinetics, relative bioavailability, formulation comparison

Brief summary

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

Interventions

DRUGPf-04937319

Formulation A) Pf-04937319 50 mg - administered as tablet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Pf-04937319: Maximum plasma concentration (Cmax)	0 - 96 hours post dose
Pf-04937319: Time for Cmax (Tmax)	0 - 96 hours post dose
Pf-04937319: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)	0 - 96 hours post dose
Pf-04937319: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)	0 - 96 hours post dose
Pf-04937319: terminal half-life (T1/2)	0 - 96 hours post dose
PF-06455349: Maximum Observed Plasma Concentration (Cmax)	0 - 96 hours post dose
PF-06455349: Time to Reach Maximum Observed Plasma Concentration (Tmax)	0 - 96 hours post dose
PF-06455349: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	0 - 96 hours post dose
PF-06455349: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]	0 - 96 hours post dose
PF-06455349: Plasma Decay Half-Life (t1/2)	0 - 96 hours post dose

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026