Coronary Artery Disease
Conditions
Keywords
CAD, Pharmacokinetics, BMS747158
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).
Interventions
DRUG[3H] BMS747158
Single bolus intravenous injection of \[3H\] BMS747158
Sponsors
Lantheus Medical Imaging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written signed informed consent prior to any study procedures 2. Be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory tests 3. Have a Body Mass Index (BMI) of 18 to 30 kg/m2 4. Be male, age 18 to 45 years 5. 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 6. Must be able to communicate effectively with study personnel
Exclusion criteria
1. Any significant active or chronic medical illness or acute significant trauma 2. History of any condition that may disrupt and/or increase permeability of the blood-brain barrier or diabetes 3. History of any neurological disease. 4. History of concussion or meningitis within the past 6 months 5. History of sleep disorders, including snoring with sleep apnea and narcolepsy 6. History of anxiety disorder 7. Current or recent GI disease 8. Major surgery within 4 weeks 9. GI surgery that could impact upon the re-absorption of study drug 10. History of chronic constipation 11. History of asthma as deemed clinically significant by the Investigator or designee 12. History of recent (within 2 weeks of enrollment) infection (e.g., upper respiratory tract infection, urinary tract infection) 13. Known and confirmed drug allergies or hypersensitivities 14. 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 15. Blood transfusion within four weeks of enrollment 16. Inability to tolerate intravenous medication or unlikely to obtain and/or tolerate venous access 17. Past (6 months) or present history of drug or alcohol abuse 18. Screening or pre-dose ECG interval abnormalities or organ dysfunction. 19. Positive urine screen for drugs of abuse either at screening or before dosing 20. Positive blood screen for hepatitis B surface antigen, hepatitis C antibody, or HIV 21. Exposure to any investigational drug, device, or placebo within four weeks of enrollment 22. Use of any prescription drugs within 4 weeks of enrollment 23. Use of any other drugs, including over-the-counter medications (e.g., acid-controllers) and herbal preparations within two weeks of enrollment 24. Smoking within 1 month of enrollment 25. Alcohol or caffeine consumption within 72 hours of study drug administration 26. Participation in a radio-labeled study within 12 months of enrollment 27. Intake of radio-labeled drug substance or exposure to significant radiation 28. Participation in any prior study with BMS747158
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed