Heart Decompensation, AcutePhase 1NCT03210909
Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
A Phase 1 study testing BMS-986231 in people with Heart Decompensation, Acute, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231 Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Decompensation, Acute
- What is being tested?
- BMS-986231
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2017to 20 Jul 2017
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed Informed Consent
- Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
- Body weight between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2.
Who cannot join
- History of chronic illness
- Chronic headaches
- Recurrent dizziness
- Personal or family history of heart disease
- Personal history of bleeding diathesis
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Madison, Wisconsin, 53704
About this study
An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231
- Conditions
- Heart Decompensation, Acute
- Being tested
- BMS-986231
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986231Drug
BMS-986231
| Study group | Role | What they receive |
|---|---|---|
| BMS-986231 Intravenous Infusion | Experimental | A single continuous intravenous infusion of BMS-986231 Receives: Drug: BMS-986231 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
Measured by plasma concentrations
Measured: Up to 8 days
Percent of Total Radioactivity Recovered in All Excreta (% total)
Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts
Measured: Up to 8 days
Half-Life (T-HALF)
Measured by plasma concentrations
Measured: Up to 8 days
Total Body Clearance (CLT)
Measured by plasma concentrations
Measured: Up to 8 days
Volume of Distribution during Terminal Elimination Phase (Vz/F)
Measured by plasma concentrations
Measured: Up to 8 days
Time to Maximum Observed Concentration (Tmax)
Measured by plasma concentrations
Measured: Up to 8 days
Secondary outcomes (4)
Incidence of adverse events (AEs)
Measured by investigator assessment
Measured: Up to 8 days
Results of electrocardiogram tests (ECGs)
Measured by investigator assessment
Measured: Up to 8 days
Results of vital sign measurements
Measured by investigator assessment
Measured: Up to 8 days
Results of clinical laboratory tests
Measured by investigator assessment
Measured: Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start22 Jun 2017
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Decompensation, AcuteStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210909
- Sponsor's protocol ID
- CV013-022
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT03210909
- Acronym / sponsor ID
- CV013-022
- Conditions
- Heart Decompensation, Acute
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 7 Jul 2017 (actual)
- 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.
An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986231 Intravenous Infusion | Experimental | Drug: BMS-986231A single continuous intravenous infusion of BMS-986231 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signed Informed Consent
- Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
- Body weight between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2.
Key exclusion criteria (6 listed)
- History of chronic illness
- Chronic headaches
- Recurrent dizziness
- Personal or family history of heart disease
- Personal history of bleeding diathesis
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 |
|---|---|---|
| BMS-986231BMS-986231 | Drug | BMS-986231 Intravenous Infusion |
Primary outcome
Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
Time frame: Up to 8 days
Measured by plasma concentrations
Percent of Total Radioactivity Recovered in All Excreta (% total)
Time frame: Up to 8 days
Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts
Half-Life (T-HALF)
Time frame: Up to 8 days
Measured by plasma concentrations
Total Body Clearance (CLT)
Time frame: Up to 8 days
Measured by plasma concentrations
Volume of Distribution during Terminal Elimination Phase (Vz/F)
Time frame: Up to 8 days
Measured by plasma concentrations
Time to Maximum Observed Concentration (Tmax)
Time frame: Up to 8 days
Measured by plasma concentrations
4 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to 8 days
Results of electrocardiogram tests (ECGs)
Time frame: Up to 8 days
Results of vital sign measurements
Time frame: Up to 8 days
Results of clinical laboratory tests
Time frame: Up to 8 days
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 1 Aug 2017.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 BMS-986231 in people with Heart Decompensation, Acute, run by Bristol-Myers Squibb 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 3 inclusion and 6 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 1 Aug 2017. 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?
Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) (time frame: Up to 8 days). The study lists 6 primary outcomes in all. 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 1 Aug 2017.