A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects
- Registration Number
- NCT01146327
- 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, and pharmacodynamics, of multiple oral doses of PF-04620110.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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 Placebo Comparator Placebo - PF-04620110 PF-04620110 -
- Primary Outcome Measures
Name Time Method To evaluate additional pharmacodynamic markers in response to multiple oral doses of PF-04620110. 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. Day 6 and Day 14
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇬Singapore, Singapore