Study of [3H] BMS747158 in Healthy Male Subjects

Completed · Phase 1

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00930631

Run by

Lantheus Medical Imaging

People needed

7

Starts

2009-06-01

Expected to finish

2010-01-01

Last updated by the study team

2020-11-10

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Covance Clinical Laboratory Unit — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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