A Phase 1, Cross-over, Single-dose, Open-label Study to Estimate the Relative Bioavailability of Three Different Formulations of Pf-04620110 Under Fed/Fasted Conditions in Healthy Adult Subjects

Pfizer1 site in 1 country12 target enrollmentJuly 2010

ConditionsHealthy

InterventionsPF-04620110

DrugsPF-04620110

Overview

Phase: Phase 1
Intervention: PF-04620110
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 12
Locations: 1
Primary Endpoint: Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, C24hr, peak trough ratio (PTR), and half life
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the relative bioavailability of three different oral dose formulations of PF-04620110.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

August 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

Inclusion Criteria

•Healthy male and/or female subjects between the ages of 21 and 55 years
•Body Mass Index (BMI) of 17.5 to 30.5 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.

Arms & Interventions

ABCE, ACBD, BACD, BCAE, CABE and CBAD

Intervention: PF-04620110

Outcomes

Primary Outcomes

Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, C24hr, peak trough ratio (PTR), and half life

Time Frame: following each treatment

Secondary Outcomes

Safety Endpoints: Safety and tolerability of PF 04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead electrocardiograms (ECGs), vital signs, and clinical safety laboratory measurements.(before, during and following treatment)