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Completed

NCT Number: NCT01513928

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

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

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Key information

Conditions

Healthy

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-04937319

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 20, 2012
Registry last updated
Mar 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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