Study of [3H] BMS747158 in Healthy Male Subjects (PPA103)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00930631
First received: June 24, 2009
Last updated: October 14, 2011
Last verified: October 2011
  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

Resource links provided by NLM:


Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • 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 ]

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 ] [ 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)
Intervention Details:
    Drug: [3H] BMS747158
    Single bolus intravenous injection of [3H] BMS747158
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).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930631

Locations
United States, Wisconsin
Covance Clinical Laboratory Unit
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014