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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014