Status:
COMPLETED
Study of [3H] BMS747158 in Healthy Male Subjects
Lead Sponsor:
Lantheus Medical Imaging
Conditions:
Coronary Artery Disease
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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...
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 \[3...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00930631
Start Date
June 1 2009
End Date
January 1 2010
Last Update
November 10 2020
Active Locations (1)
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1
Covance Clinical Laboratory Unit
Madison, Wisconsin, United States, 53704