Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate
- Registration Number
- NCT01199029
- Lead Sponsor
- Pfizer
- Brief Summary
This study will investigate the effect of a single dose of PF-04308515 or prednisone on calculated measures of glucose tolerance and insulin resistance by using a modified oral glucose tolerance test.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
Inclusion Criteria
- BMI 17.5 to 30.5 kg/m2 and total body weight >50 kg
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Exclusion Criteria
- Fasting glucose above the limits of the reference range for healthy individuals
- "No treatment" OGTT indicative of impaired fasting glucose or impaired glucose tolerance
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description (Part 1) 10 mg PF-04308515 (8hrs) PF-04308515 - (Part 1) 10 mg PF-04308515 (12hrs) PF-04308515 - (Part 2) X mg PF-04308515 PF-04308515 - (Part 2) Y mg PF-04308515 PF-04308515 - (Part 2) 5 mg Prednisone Prednisone - (Part 2) 20 mg Prednisone Prednisone - (Part 1) 5 mg Prednisone Prednisone -
- Primary Outcome Measures
Name Time Method Fold change in AUC (0-4hr) relative to no treatment baseline for plasma glucose, plasma insulin and plasma C-peptide 4 hours
- Secondary Outcome Measures
Name Time Method Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma C-peptide 3 days Safety: adverse events, vital sign measurements, physical examination 3 days Pharmacokinetics: sparse PF-04308515 plasma samples will be collected 3 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Kalamazoo, Michigan, United States