NCT01102673

Single Dose Study of PF-04991532 in Healthy Subjects

A Phase 1 Placebo-Controlled Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Food Effect of Single Escalating Oral Doses of PF-04991532 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK) and preliminary food effect of PF-04991532 following single escalating oral doses in healthy adult subjects.

Detailed description

Safety/Tolerability and PK

Conditions

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Metabolism Disorders

Interventions

Type	Name	Description
DRUG	PF-04991532	The tentative dosing schedule is 30, 100, 300, 600, 1200, and 2000 mg. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as extemporaneously-prepared powder in capsule (PIC) formulation.
DRUG	Placebo	Placebo to match PF-04991532 will be provided

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-04-13
• Last updated: 2010-08-05

Locations

1 site across 1 country: United States