Coronary Artery DiseasePhase 1PPA103NCT00930631
Study of [3H] BMS747158 in Healthy Male Subjects
A Phase 1 study testing [3H] BMS747158 in people with Coronary Artery Disease, run by Lantheus Medical Imaging at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- [3H] BMS747158
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jan 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Laboratory Unit
Madison, Wisconsin, 53704
About this study
Official title: Pharmacokinetics, Metabolism and Elimination of Tritiated [3H] BMS747158 in Healthy Male Subjects
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.
Read the 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).
- Conditions
- Coronary Artery Disease
- Being tested
- [3H] BMS747158
- Keywords
- CAD, Pharmacokinetics, BMS747158
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[3H] BMS747158Drug
Single bolus intravenous injection of [3H] BMS747158
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Single arm PK study Receives: Drug: [3H] BMS747158 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: August 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Debra A Mandarino, MD, Principal investigator, Covance Clinical Laboratory Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930631
- Sponsor's protocol ID
- BMS747158-103
- Acronym
- PPA103
- Status last verified
- Oct 2011
- First submitted
- 24 Jun 2009
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Metabolism and Elimination of Tritiated [3H] BMS747158 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00930631
- Acronym / sponsor ID
- PPA103 / BMS747158-103
- Conditions
- Coronary Artery Disease
- Keywords
- CAD, Pharmacokinetics, BMS747158
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Lantheus Medical ImagingIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Drug: [3H] BMS747158Single arm PK study |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [3H] BMS747158Single bolus intravenous injection of [3H] BMS747158 | Drug | Single Arm |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra A Mandarino, MD principal investigator
Covance Clinical Laboratory Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [3H] BMS747158 in people with Coronary Artery Disease, run by Lantheus Medical Imaging at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.