A Single Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers
- Registration Number
- NCT00799006
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
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)
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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).
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo - PF-04620110 PF-04620110 -
- 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, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements. 4 days/dose group The single dose pharmacokinetics of PF-04620110 will be assessed 4 days/dose group
- Secondary Outcome Measures
Name Time Method Secondary pharmacodynamic endpoints will include postprandial lipid metabolism measures 1 day/dose group
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States