Clinical trial NCT01513928: A Study To Compare The Pharmacokinetics Of Different Formulations Of PF-04937319 In Healthy Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
relative bioavailability
formulation comparison
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-01-20
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility 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.

Primary outcomes:
measure: Pf-04937319: Maximum plasma concentration (Cmax)
timeFrame: 0 - 96 hours post dose
measure: Pf-04937319: Time for Cmax (Tmax)
timeFrame: 0 - 96 hours post dose
measure: Pf-04937319: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
timeFrame: 0 - 96 hours post dose
measure: Pf-04937319: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
timeFrame: 0 - 96 hours post dose
measure: Pf-04937319: terminal half-life (T1/2)
timeFrame: 0 - 96 hours post dose
measure: PF-06455349: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0 - 96 hours post dose
measure: PF-06455349: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0 - 96 hours post dose
measure: PF-06455349: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0 - 96 hours post dose
measure: PF-06455349: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
timeFrame: 0 - 96 hours post dose
measure: PF-06455349: Plasma Decay Half-Life (t1/2)
timeFrame: 0 - 96 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: