Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 1 Multiple Doses Safety Pharmacokinetics Pharmacodynamics Healthy Volunteers Type 2 Diabetic Patients
Allocation: RANDOMIZED | Intervention model: 
Enrollment: 64
Healthy volunteers: yes

Brief summary:
The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of PF-05175157 in healthy volunteers and patients with type 2 diabetes mellitus.

Detailed description:

Arms:
arm 1: None arm 2: Planned dose might be modified based on emerging safety and PK data. arm 3: Planned dose might be modified based on emerging safety and PK data. arm 4: Planned dose might be modified based on emerging safety and PK data. arm 5: Dose will be determined based on results obtained from Arms 1 to 4.

Interventions: intervention 1: PF-05175157 or Placebo intervention 2: PF-05175157 or Placebo intervention 3: PF-05175157 or Placebo intervention 4: PF-05175157 or Placebo intervention 5: PF-05175157 or Placebo
Intervention descriptions: intervention 1: One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers. intervention 2: One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers. intervention 3: One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers. intervention 4: One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule twice daily for 14 days, immediately before breakfast and dinner, in healthy volunteers. intervention 5: One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once (or twice) daily for 14 days, immediately before breakfast (and dinner), in patients with type 2 diabetes.

Protocol document: