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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
7
Single bolus intravenous injection of \[3H\] BMS747158
Covance Clinical Laboratory Unit
Madison, Wisconsin, United States
To assess safety and the extent and route of [3H] radioactivity eliminated (mass balance) in urine and feces following a single intravenous (IV) dose of approximately 100 (±20) µCi of [3H] BMS747158 in healthy male subjects.
Time frame: August 2009
To assess the pharmacokinetics (PK) of [3H] radioactivity and of [3H] BMS747158 in blood. To identify the major metabolites of [3H] BMS747158 present in blood, urine, and feces
Time frame: August 2009
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.