Study of [3H] BMS747158 in Healthy Male Subjects (PPA103)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: [3H] BMS747158 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Pharmacokinetics, Metabolism and Elimination of Tritiated [3H] BMS747158 in Healthy Male Subjects |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 7 |
| Study Start Date: | June 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
-
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).
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Wisconsin | |
| Covance Clinical Laboratory Unit | |
| Madison, Wisconsin, United States, 53704 | |
| Principal Investigator: | Debra A Mandarino, MD | Covance Clinical Laboratory Unit |
More Information
No publications provided
| Responsible Party: | Lantheus Medical Imaging |
| ClinicalTrials.gov Identifier: | NCT00930631 History of Changes |
| Other Study ID Numbers: | BMS747158-103 |
| Study First Received: | June 24, 2009 |
| Last Updated: | October 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Lantheus Medical Imaging:
|
CAD Pharmacokinetics BMS747158 |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013