A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Multiple Escalating Oral Doses Of PF-04620110 In Otherwise Healthy Overweight And Obese Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- PF-04620110
- Conditions
- Obesity
- Sponsor
- Pfizer
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 15 years ago
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, pharmacokinetics, and pharmacodynamics, of multiple oral doses of PF-04620110.
Investigators
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 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.
Time Frame: Baseline to 2 weeks
To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.
Time Frame: Baseline to 2 weeks
To characterize the effect of PF-04620110 on postprandial lipid metabolism measures.
Time Frame: Baseline to 2 weeks
Secondary Outcomes
- 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)
- 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)
- Additional Secondary Pharmacodynamic Endpoint: Fasting adiponectin(Day -1 and Day 14)