Study of [3H] BMS747158 in Healthy Male Subjects (PPA103)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[3H] BMS747158
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring CAD, Pharmacokinetics, BMS747158
Eligibility Criteria
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
Sites / Locations
- Covance Clinical Laboratory Unit
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
Single arm PK study
Outcomes
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.
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
Full Information
NCT ID
NCT00930631
First Posted
June 24, 2009
Last Updated
November 6, 2020
Sponsor
Lantheus Medical Imaging
1. Study Identification
Unique Protocol Identification Number
NCT00930631
Brief Title
Study of [3H] BMS747158 in Healthy Male Subjects
Acronym
PPA103
Official Title
Pharmacokinetics, Metabolism and Elimination of Tritiated [3H] BMS747158 in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lantheus Medical Imaging
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CAD, Pharmacokinetics, BMS747158
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
Single arm PK study
Intervention Type
Drug
Intervention Name(s)
[3H] BMS747158
Intervention Description
Single bolus intravenous injection of [3H] BMS747158
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra A Mandarino, MD
Organizational Affiliation
Covance Clinical Laboratory Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Covance Clinical Laboratory Unit
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of [3H] BMS747158 in Healthy Male Subjects
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