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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513928
• Other study ID #: B1621005
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2012
• Last updated: March 8, 2012
• Start date: January 2012
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Pf-04937319
Formulation A) Pf-04937319 50 mg - administered as tablet
• Pf-04937319
Formulation B) Pf-04937319 50 mg - administered as capsule
• Pf-04937319
Formulation C) Pf-04937319 50 mg - administered as capsule

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pf-04937319: Maximum plasma concentration (Cmax)		0 - 96 hours post dose	No
Primary	Pf-04937319: Time for Cmax (Tmax)		0 - 96 hours post dose	No
Primary	Pf-04937319: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)		0 - 96 hours post dose	No
Primary	Pf-04937319: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)		0 - 96 hours post dose	No
Primary	Pf-04937319: terminal half-life (T1/2)		0 - 96 hours post dose	No
Primary	PF-06455349: Maximum Observed Plasma Concentration (Cmax)		0 - 96 hours post dose	No
Primary	PF-06455349: Time to Reach Maximum Observed Plasma Concentration (Tmax)		0 - 96 hours post dose	No
Primary	PF-06455349: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)		0 - 96 hours post dose	No
Primary	PF-06455349: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]		0 - 96 hours post dose	No
Primary	PF-06455349: Plasma Decay Half-Life (t1/2)		0 - 96 hours post dose	No

External Links

•   To obtain contact information for a study center near you, click here.