Study of [3H] BMS747158 in Healthy Male Subjects (PPA103)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Condition or disease
Coronary Artery Disease
Drug: [3H] BMS747158
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).
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 ]
Secondary Outcome Measures :
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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