A Multiple Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers

Phase 1

Completed

• Conditions: Obesity; Overweight; Healthy
• Interventions: Drug: PF-04620110; Drug: Placebo

• Registration Number: NCT00959426
• Lead Sponsor: Pfizer

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, pharmacokinetics, and pharmacodynamics, of multiple oral doses of PF-04620110.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-03
• Last Update Posted: 2010-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-04620110	PF-04620110	-
Placebo Comparator	Placebo	-

Primary Outcome Measures

Name	Time	Method
To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, andc linical safety laboratory measurements.	Baseline to 2 weeks
To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.	Baseline to 2 weeks
To characterize the effect of PF-04620110 on postprandial lipid metabolism measures.	Baseline to 2 weeks

Secondary Outcome Measures

Name	Time	Method
To examine additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.	Day -1 and Day 14
Secondary Pharmacodynamic Endpoints in response to a liquid meal test	Day -1 and Day 14
Triglyceride excursions	Day -1, Day 1, and Day 14
Glucose, insulin, and C-peptide excursions	Day -1 and Day 14
Gut hormone excursions- including active GLP-1, total amide GLP-1, ghrelin, GIP, and PYY	Day -1 and Day 14
Additional Secondary Pharmacodynamic Endpoint: Fasting adiponectin	Day -1 and Day 14

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States