A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Escalating Oral Doses Of PF-04620110 In Otherwise Healthy Overweight And Obese Subjects

Pfizer1 site in 1 country27 target enrollmentNovember 2008

ConditionsOverweight

InterventionsPlacebo PF-04620110

DrugsPlacebo PF-04620110

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Overweight
Sponsor: Pfizer
Enrollment: 27
Locations: 1
Primary Endpoint: To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements.
Status: Completed
Last Updated: 16 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 purpose of this study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics following a single oral dose.

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

June 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

Inclusion Criteria

•Healthy male and/or female subjects between the ages of 18 and 55 years
•Body Mass Index (BMI) of approximately 27 to 35 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Arms & Interventions

Placebo

Intervention: Placebo

PF-04620110

Intervention: PF-04620110

Outcomes

Primary Outcomes

To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements.

Time Frame: 4 days/dose group

The single dose pharmacokinetics of PF-04620110 will be assessed

Time Frame: 4 days/dose group