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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Pf-04937319
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: January 2012
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513928

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01513928     History of Changes
Other Study ID Numbers: B1621005
Study First Received: January 17, 2012
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
pharmacokinetics
relative bioavailability
formulation comparison

ClinicalTrials.gov processed this record on April 15, 2014