Study of [3H] BMS747158 in Healthy Male Subjects

Study Overview
=================
Brief 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).

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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: [3H] BMS747158


Participation Criteria
=================
Eligibility Criteria
-----------------
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: a male condom with spermicide a sterile sexual partner use by female sexual partner of an intrauterine device (IUD) with spermicide *a female condom with spermicide contraceptive sponge with spermicide an intravaginal system [e.g., NuvaRing®] a diaphragm with spermicide a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives Must be able to communicate effectively with study personnel Exclusion Criteria: Any significant active or chronic medical illness or acute significant trauma History of any condition that may disrupt and/or increase permeability of the blood-brain barrier or diabetes History of any neurological disease. History of concussion or meningitis within the past 6 months History of sleep disorders, including snoring with sleep apnea and narcolepsy History of anxiety disorder Current or recent GI disease Major surgery within 4 weeks GI surgery that could impact upon the re-absorption of study drug History of chronic constipation History of asthma as deemed clinically significant by the Investigator or designee History of recent (within 2 weeks of enrollment) infection (e.g., upper respiratory tract infection, urinary tract infection) Known and confirmed drug allergies or hypersensitivities Donation of blood and/or plasma to a blood bank or in a clinical study (except as required for screening) within four weeks of enrollment Blood transfusion within four weeks of enrollment Inability to tolerate intravenous medication or unlikely to obtain and/or tolerate venous access Past (6 months) or present history of drug or alcohol abuse Screening or pre-dose ECG interval abnormalities or organ dysfunction. Positive urine screen for drugs of abuse either at screening or before dosing Positive blood screen for hepatitis B surface antigen, hepatitis C antibody, or HIV Exposure to any investigational drug, device, or placebo within four weeks of enrollment Use of any prescription drugs within 4 weeks of enrollment Use of any other drugs, including over-the-counter medications (e.g., acid-controllers) and herbal preparations within two weeks of enrollment Smoking within 1 month of enrollment Alcohol or caffeine consumption within 72 hours of study drug administration Participation in a radio-labeled study within 12 months of enrollment Intake of radio-labeled drug substance or exposure to significant radiation Participation in any prior study with BMS747158

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Single arm PK study | Drug: [3H] BMS747158<br>* Single bolus intravenous injection of [3H] BMS747158<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAD, Pharmacokinetics, BMS747158