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

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ClinicalTrials.gov Identifier: NCT01513928
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : March 12, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is designed to compare the pharmacokinetics of three different formulations of Pf-04937319

Condition or disease Intervention/treatment Phase
Healthy Drug: Pf-04937319 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2012
Primary Completion Date : February 2012
Study Completion Date : February 2012
Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Pf-04937319: Maximum plasma concentration (Cmax) [ Time Frame: 0 - 96 hours post dose ]
  2. Pf-04937319: Time for Cmax (Tmax) [ Time Frame: 0 - 96 hours post dose ]
  3. 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 ]
  4. Pf-04937319: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) [ Time Frame: 0 - 96 hours post dose ]
  5. Pf-04937319: terminal half-life (T1/2) [ Time Frame: 0 - 96 hours post dose ]
  6. PF-06455349: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 - 96 hours post dose ]
  7. PF-06455349: Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 - 96 hours post dose ]
  8. PF-06455349: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0 - 96 hours post dose ]
  9. PF-06455349: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0 - 96 hours post dose ]
  10. PF-06455349: Plasma Decay Half-Life (t1/2) [ Time Frame: 0 - 96 hours post dose ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01513928     History of Changes
Other Study ID Numbers: B1621005
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: March 2012

Keywords provided by Pfizer:
pharmacokinetics
relative bioavailability
formulation comparison