Study of [3H] BMS747158 in Healthy Male Subjects

NCT00930631 | Completed Phase 1

• 1 other identifier: BMS747158-103
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

CAD; Pharmacokinetics; BMS747158

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Single Arm

OTHER

Single arm PK study

Drug: [3H] BMS747158

Interventions

[3H] BMS747158 DRUG

Single bolus intravenous injection of \[3H\] BMS747158

Single Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Lantheus Medical Imaging: lead

Study Sites (1)

Covance Clinical Laboratory Unit

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Debra A Mandarino, MD

  Covance Clinical Laboratory Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 30, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: January 1, 2010
• Last Updated: November 10, 2020

Record last verified: 2011-10

Locations

US (1)