NCT00979368

Safety Study of BMS-816336 in Healthy Male Subjects

Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-816336 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.

Conditions

• Diabetes Mellitus, Non-Insulin-Dependent
• Dyslipidemia

Interventions

Type	Name	Description
DRUG	BMS-816336	Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days
DRUG	BMS-816336	Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days
DRUG	BMS-816336	Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days
DRUG	BMS-816336	Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days
DRUG	BMS-816336	Suspension, Oral, 900 mg Active, Once on Day 1 only, 4 days
DRUG	Placebo	Suspension, Oral, 0 mg, Once on Day 1 only, 4 days

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-09-18
• Last updated: 2011-02-23

Locations

1 site across 1 country: Australia