Study of [3H] BMS747158 in Healthy Male Subjects

Coronary Artery Disease Clinical Trial

— PPA103  

Official title:

Pharmacokinetics, Metabolism and Elimination of Tritiated [3H] BMS747158 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930631
• Other study ID #: BMS747158-103
• Status: Completed
• Phase: Phase 1
• Start date: June 2009
• Est. completion date: January 2010

Study information

• Verified date: October 2011
• Source: Lantheus Medical Imaging
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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] BMS747158 administration will also be assessed, as well as pharmacokinetics of [3H] BMS747158 and metabolite identification.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• [3H] BMS747158
Single bolus intravenous injection of [3H] BMS747158

Locations

Country	Name	City	State
United States	Covance Clinical Laboratory Unit	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Lantheus Medical Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		August 2009
Secondary	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		August 2009