NCT01199029CompletedPhase 1
An Open Label Study Evaluating The Effect Of Single Doses Of Pf-04308515 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Fold change in AUC (0-4hr) relative to no treatment baseline for plasma glucose, plasma insulin and plasma C-peptide
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •BMI 17.5 to 30.5 kg/m2 and total body weight >50 kg
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
Arms & Interventions
(Part 1) 10 mg PF-04308515 (8hrs)
Experimental
Intervention: PF-04308515 (Drug)
(Part 1) 10 mg PF-04308515 (12hrs)
Experimental
Intervention: PF-04308515 (Drug)
(Part 1) 5 mg Prednisone
Active Comparator
Intervention: Prednisone (Drug)
(Part 2) X mg PF-04308515
Experimental
Intervention: PF-04308515 (Drug)
(Part 2) Y mg PF-04308515
Experimental
Intervention: PF-04308515 (Drug)
(Part 2) 5 mg Prednisone
Active Comparator
Intervention: Prednisone (Drug)
(Part 2) 20 mg Prednisone
Active Comparator
Intervention: Prednisone (Drug)
Outcomes
Primary Outcomes
Fold change in AUC (0-4hr) relative to no treatment baseline for plasma glucose, plasma insulin and plasma C-peptide
Time Frame: 4 hours
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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