A Phase 1, Parallel, Randomized Trial To Assess The Effect Of Time Of Dosing On The Pharmacodynamics, Pharmacokinetics, Safety And Tolerability Of Multiple Oral Doses Of PF-04620110 In Otherwise Healthy Overweight Or Obese Adult Subjects

Pfizer1 site in 1 country60 target enrollmentJune 2010

ConditionsHealthy

InterventionsPF-04620110 Placebo

DrugsPF-04620110 Placebo

Overview

Phase: Phase 1
Intervention: PF-04620110
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 60
Locations: 1
Primary Endpoint: To evaluate additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.
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 safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

January 2011

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 18 and 55 years
•Body Mass Index (BMI) of 26.5 to 35.5 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

PF-04620110

Intervention: PF-04620110

Placebo Comparator

Intervention: Placebo

Outcomes

Primary Outcomes

To evaluate additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.

Time Frame: Day 1 to Day 13

To evaluate secondary Pharmacodynamic Endpoints in response to a liquid meal test in response to multiple oral doses of PF-04620110.

Time Frame: Day 6 and Day 14

Secondary Outcomes

To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.(Baseline to 2 weeks)
To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, and clinical safety laboratory measurements.(Baseline to 2 weeks)