Conditions: Type 2 Diabetes Mellitus
Keywords: phase 1 safety and tolerability PK PD type 2 diabetes mellitus T2DM
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

Brief summary:
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04937319 following single escalating oral doses in adult subjects with Type 2 Diabetes Mellitus (T2DM).

Detailed description:
The purpose of this phase 1 study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF04937319 following single escalating oral doses in adult subjects with T2DM.

Arms:
arm 1: In each ascending-dose cohort, approximately 6 subjects will receive active treatment and 3 will receive placebo. arm 2: In each ascending-dose cohort, approximately 6 subjects will receive active treatment and 3 will receive placebo. There will be approximately 6 dosing levels of PF-04937319

Interventions: intervention 1: Placebo intervention 2: PF-04937319
Intervention descriptions: intervention 1: Placebo to match PF-04937319 will be provided. intervention 2: The initial planned dosing schedule is: 10, 30, 100, 200, and 400 mg, with one cohort to be determined. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as a single oral dose as a powder-in-capsule (PIC) formulation. PF-04937319 will be supplied as 10 mg and 80 mg (and potentially 1 mg) PIC.

Protocol document: