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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Pf-04937319; Drug: Pf-04937319; Drug: Pf-04937319

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 188770
    • Pfizer Investigational Site

Participation Criteria

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: January 19, 2012
• First Posted (Estimate): January 20, 2012

Study Record Updates

• Last Update Posted (Estimate): March 12, 2012
• Last Update Submitted That Met QC Criteria: March 8, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: pharmacokinetics; relative bioavailability; formulation comparison
• Other Study ID Numbers: B1621005