NCT01369277

A Single Dose Study In Japanese And Western Healthy Subjects To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-04991532

A Phase 1, Randomized, Double Blind, Placebo-Controlled, Single Dose Escalation Study In Japanese Healthy Subjects, And Open Label, Single Dose Study In Western Healthy Subjects To Investigate The Safety, Tolerability, And Pharmacokinetics of PF-04991532.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is to investigate the safety, tolerability and pharmacokinetics of single ascending oral doses of PF-04991532 in Japanese healthy subjects. The secondary objective is to investigate the pharmacokinetics and safety of single ascending oral doses of PF-04991532 in Western healthy subjects and to compare the pharmacokinetics between Japanese and Western healthy subjects.

Detailed description

Safety/Tolerability and Pharmacokinetics

Conditions

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

Interventions

Type	Name	Description
DRUG	PF-04991532	Single dose administration of PF-04991532 (100 mg, 300 mg and 750 mg) in tablet formulation under fasted condition.
DRUG	Placebo	Single dose administration of matching placebo in tablet formulation at the fasted state
DRUG	PF-04991532	Single dose administration of PF-04991532 (300 mg and 750 mg) in tablet formulation under fasted condition.

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-06-08
• Last updated: 2011-09-22

Locations

1 site across 1 country: United States