NCT00930631

Study of [3H] BMS747158 in Healthy Male Subjects

Pharmacokinetics, Metabolism and Elimination of Tritiated [3H] BMS747158 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Lantheus Medical Imaging · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical study is to assess the safety, extent and route of \[3H\] BMS747158 radioactivity eliminated (mass balance) in urine and feces of healthy male subjects. The safety of \[3H\] BMS747158 administration will also be assessed, as well as pharmacokinetics of \[3H\] BMS747158 and metabolite identification.

Detailed description

This Phase I, nonrandomized, open-label study will enroll up to seven healthy male subjects who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 100 (±20) μCi of \[3H\] BMS747158. Subjects will undergo blood, urine, and fecal collections to evaluate \[3H\] activity for a minimum of 7 days post-dose. Safety will be assessed by monitoring of adverse events (AEs), vital signs, physical examinations, clinical laboratory tests, and electrocardiograms (ECGs).This Phase I, nonrandomized, open-label study will enroll up to seven healthy male subjects who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 100 (±20) μCi of \[3H\] BMS747158. Subjects will undergo blood, urine, and fecal collections to evaluate \[3H\] activity for a minimum of 7 days post-dose. Safety will be assessed by monitoring of adverse events (AEs), vital signs, physical examinations, clinical laboratory tests, and electrocardiograms (ECGs).

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	[3H] BMS747158	Single bolus intravenous injection of \[3H\] BMS747158

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-07-01
• Completion: 2010-01-01
• First posted: 2009-06-30
• Last updated: 2020-11-10

Locations

1 site across 1 country: United States