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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | Single arm PK study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [3H] BMS747158 | Drug | Single bolus intravenous injection of [3H] BMS747158 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | August 2009 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | August 2009 |
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Inclusion Criteria:
Provide written signed informed consent prior to any study procedures
Be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory tests
Have a Body Mass Index (BMI) of 18 to 30 kg/m2
Be male, age 18 to 45 years
Be sterile or agree to use from admission until discharge one of the following approved methods of contraception:
Must be able to communicate effectively with study personnel
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra A Mandarino, MD | Covance Clinical Laboratory Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Laboratory Unit | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |