Healthy VolunteersPhase 1NCT05847439
A Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants
A Phase 1 study testing [14C]BMS-986419 in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetics (PK), metabolite profile, routes and extent of elimination, mass balance, as well as safety and tolerability of [14C]BMS-986419 in healthy male participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]BMS-986419
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2023to 5 Jul 2023
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 18.0 and 33.0 kilograms/meter square (kg/m^2), inclusive, at screening. Body mass index = weight (kg)/(height [m])2.
- Healthy male participants as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [for example, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -2).
Who cannot join
- Any significant acute or chronic medical conditions.
- Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery (for example, cholecystectomy and any other gastrointestinal surgery) that could impact the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could impact the absorption of study treatment.
- Note: Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp Clinical Research Unit - Madison
Madison, Wisconsin, 53704-2526
About this study
Official title: A Phase 1, Single-center, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants
The purpose of this study is to assess the pharmacokinetics (PK), metabolite profile, routes and extent of elimination, mass balance, as well as safety and tolerability of [14C]BMS-986419 in healthy male participants.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]BMS-986419
- Keywords
- Pharmacokinetics, Metabolite profile, Radioactivity, BMS-986419, Healthy volunteer, Healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]BMS-986419Drug
Also called BMS-986419, EOAI4018683
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| [14C]BMS-986419 | Experimental | Not described Receives: Drug: [14C]BMS-986419 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to Day 20
Time of maximum plasma observed concentration (Tmax)
Measured: Up to Day 20
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Measured: Up to Day 20
Total radioactivity recovered in urine (UR)
Measured: Up to Day 30
Total radioactivity recovered in feces (FR)
Measured: Up to Day 30
Total radioactivity recovered in bile (BR)
Measured: Up to Day 30
Total radioactivity recovered (Rtotal)
Measured: Up to Day 30
Percent of total radioactivity recovered (%Total)
Measured: Up to Day 30
Percent of total radioactivity recovered in urine (%UR)
Measured: Up to Day 30
Percent of total radioactivity recovered in feces (%FR)
Measured: Up to Day 30
Secondary outcomes (7)
Number of Participants with Adverse Events (AEs)
Measured: Up to Day 60
Number of Participants with Serious AEs (SAEs)
Measured: Up to Day 60
Number of Participants with AEs leading to discontinuation
Measured: Up to Day 60
Number of Participants with Vital Sign Abnormalities
Measured: Up to Day 30
Number of Participants with Electrocardiogram (ECG) Abnormalities
Measured: Up to Day 30
Number of Participants with Physical Examination Abnormalities
Measured: Up to Day 30
Number of Participants with Clinical Laboratory Abnormalities
Measured: Up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start5 May 2023
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 8 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
- NCT05847439
- Sponsor's protocol ID
- CN007-1004
- Status last verified
- Sep 2023
- First submitted
- 27 Apr 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT05847439
- Acronym / sponsor ID
- CN007-1004
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, Metabolite profile, Radioactivity, BMS-986419, Healthy volunteer, Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 May 2023 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 6 May 2023 (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.
The purpose of this study is to assess the pharmacokinetics (PK), metabolite profile, routes and extent of elimination, mass balance, as well as safety and tolerability of [14C]BMS-986419 in healthy male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]BMS-986419 | Experimental | Drug: [14C]BMS-986419 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index between 18.0 and 33.0 kilograms/meter square (kg/m^2), inclusive, at screening. Body mass index = weight (kg)/(height [m])2.
- Healthy male participants as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [for example, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -2).
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical conditions.
- Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery (for example, cholecystectomy and any other gastrointestinal surgery) that could impact the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could impact the absorption of study treatment.
- Note: Other protocol-defined inclusion/exclusion criteria apply.
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 |
|---|---|---|
| [14C]BMS-986419Also: BMS-986419, EOAI4018683Specified dose on specified days | Drug | [14C]BMS-986419 |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 20
Time of maximum plasma observed concentration (Tmax)
Time frame: Up to Day 20
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time frame: Up to Day 20
Total radioactivity recovered in urine (UR)
Time frame: Up to Day 30
Total radioactivity recovered in feces (FR)
Time frame: Up to Day 30
Total radioactivity recovered in bile (BR)
Time frame: Up to Day 30
Total radioactivity recovered (Rtotal)
Time frame: Up to Day 30
Percent of total radioactivity recovered (%Total)
Time frame: Up to Day 30
Percent of total radioactivity recovered in urine (%UR)
Time frame: Up to Day 30
Percent of total radioactivity recovered in feces (%FR)
Time frame: Up to Day 30
7 secondary outcomes
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 60
Number of Participants with Serious AEs (SAEs)
Time frame: Up to Day 60
Number of Participants with AEs leading to discontinuation
Time frame: Up to Day 60
Number of Participants with Vital Sign Abnormalities
Time frame: Up to Day 30
Number of Participants with Electrocardiogram (ECG) Abnormalities
Time frame: Up to Day 30
Number of Participants with Physical Examination Abnormalities
Time frame: Up to Day 30
Number of Participants with Clinical Laboratory Abnormalities
Time frame: Up to Day 30
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 2 Oct 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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Healthy Participants
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 [14C]BMS-986419 in people with Healthy Volunteers, 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 2 inclusion and 4 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 2 Oct 2023. 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?
Maximum observed plasma concentration (Cmax) (time frame: Up to Day 20). The study lists 10 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 2 Oct 2023.