Conditions: Type 2 Diabetes Mellitus
Keywords: Phase 1 bioavailability type 2 diabetes mellitus PF-04937319
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 39
Healthy volunteers: no

Brief summary:
Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three modified release formulations of PF-04937319 compared with the immediate release material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.

Detailed description:

Arms:
arm 1: Reference formulation arm 2: Test MR #1 arm 3: Test MR #2 arm 4: Test MR #3

Interventions: intervention 1: PF-04937319 IR MST intervention 2: PF-04937319 MR 1 intervention 3: PF-04937319 MR 2 intervention 4: PF-04937319 MR 3
Intervention descriptions: intervention 1: Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch intervention 2: Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST intervention 3: Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST intervention 4: Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST

Protocol document: