Healthy VolunteersPhase 1NCT06433505
A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
A Phase 1 study testing BMS-986365, [14C] BMS-986365 and [14C] BMS-986409 + BMS-986410 in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986365, [14C] BMS-986365 and [14C] BMS-986409 + BMS-986410
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2024to 28 Feb 2025
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations, as determined by the investigator
- Participants will require a left ventricular ejection fraction of > 50% at screening.
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height [m])2.
Who cannot join
- Any current or recent significant acute or chronic illness.
- Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QTcF interval (> 450 ms) at screening.
- Current or recent (within 3 months of intervention administration) gastrointestinal disease that could affect the absorption of study drug including cholecystectomy. Mild gastroesophageal reflux (even if managed with avoidance of food triggers) is exclusionary.
- History of allergy to BMS-986365 or related compounds.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Two-Part Study to Evaluate the Pharmacokinetics, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986365, [14C] BMS-986365, [14C] BMS-986409 + BMS-986410, [14C] BMS-986410 + BMS-986409
- Keywords
- BMS-986365, Pharmacokinetics, Absolute Bioavailability, Healthy Male Volunteers, CC-94676, ADME
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986365Drug
Specified dose on specified days
[14C] BMS-986365Drug
Specified dose on specified days.
[14C] BMS-986409 + BMS-986410Drug
Specified dose on specified days
[14C] BMS-986410 + BMS-986409Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Not described Receives: Drug: BMS-986365; Drug: [14C] BMS-986365 |
| Part B - Arm 1 | Experimental | Not described Receives: Drug: [14C] BMS-986409 + BMS-986410 |
| Part B - Arm 2 | Experimental | Not described Receives: Drug: [14C] BMS-986410 + BMS-986409 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Part A and B
Measured: Up to Day 60
Time of maximum observed concentration (Tmax)
Part A and B
Measured: Up to Day 60
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Part A and B
Measured: Up to Day 60
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF))
Part A and B
Measured: Up to Day 60
Apparent terminal plasma half-life (T-HALF)
Part A and B
Measured: Up to Day 60
Total body clearance (CLT)
Part A
Measured: Up to Day 15
Apparent total body clearance (CLT/F)
Part A and B
Measured: Up to Day 60
Mean residence time (MRT)
Part A
Measured: Up to Day 15
Apparent volume of distribution (Vz)
Part A
Measured: Up to Day 15
Apparent volume of distribution (Vz/F)
Part A and B
Measured: Up to Day 60
Absolute bioavailability (F)
Part A
Measured: Up to Day 15
Secondary outcomes (7)
Number of participants with Adverse Events
Part A and B
Measured: Up to Day 60
Number of participants with Serious Adverse Events
Part A and B
Measured: Up to Day 60
Number of participants with AEs leading to discontinuation
Part A and B
Measured: Up to Day 60
Number of participants with Vital sign abnormalities
Part A and B
Measured: Up to Day 60
Number of participants with electrocardiogram (ECG) abnormalities
Part A and B
Measured: Up to Day 60
Number of participants with physical examination abnormalities
Part A and B
Measured: Up to Day 60
Number of participants with clinical laboratory abnormalities
Part A and B
Measured: Up to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start30 May 2024
- Primary completion14 Feb 2025
- Study completion28 Feb 2025
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 CelgeneThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- 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
- NCT06433505
- Sponsor's protocol ID
- CA071-1005
- Status last verified
- Mar 2025
- First submitted
- 23 May 2024
- Last updated
- 26 Mar 2025
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Two-Part Study to Evaluate the Pharmacokinetics, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06433505
- Acronym / sponsor ID
- CA071-1005
- Conditions
- Healthy Volunteers
- Keywords
- BMS-986365, Pharmacokinetics, Absolute Bioavailability, Healthy Male Volunteers, CC-94676, ADME
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 30 May 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 29 May 2024 (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 objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: BMS-986365, Drug: [14C] BMS-986365 |
| Part B - Arm 1 | Experimental | Drug: [14C] BMS-986409 + BMS-986410 |
| Part B - Arm 2 | Experimental | Drug: [14C] BMS-986410 + BMS-986409 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations, as determined by the investigator
- Participants will require a left ventricular ejection fraction of > 50% at screening.
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height [m])2.
Key exclusion criteria (5 listed)
- Any current or recent significant acute or chronic illness.
- Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QTcF interval (> 450 ms) at screening.
- Current or recent (within 3 months of intervention administration) gastrointestinal disease that could affect the absorption of study drug including cholecystectomy. Mild gastroesophageal reflux (even if managed with avoidance of food triggers) is exclusionary.
- History of allergy to BMS-986365 or related compounds.
- 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 |
|---|---|---|
| BMS-986365Specified dose on specified days | Drug | Part A |
| [14C] BMS-986365Specified dose on specified days. | Drug | Part A |
| [14C] BMS-986409 + BMS-986410Specified dose on specified days | Drug | Part B - Arm 1 |
| [14C] BMS-986410 + BMS-986409Specified dose on specified days | Drug | Part B - Arm 2 |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Up to Day 60
Part A and B
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 60
Part A and B
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 60
Part A and B
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF))
Time frame: Up to Day 60
Part A and B
Apparent terminal plasma half-life (T-HALF)
Time frame: Up to Day 60
Part A and B
Total body clearance (CLT)
Time frame: Up to Day 15
Part A
Apparent total body clearance (CLT/F)
Time frame: Up to Day 60
Part A and B
Mean residence time (MRT)
Time frame: Up to Day 15
Part A
Apparent volume of distribution (Vz)
Time frame: Up to Day 15
Part A
Apparent volume of distribution (Vz/F)
Time frame: Up to Day 60
Part A and B
Absolute bioavailability (F)
Time frame: Up to Day 15
Part A
7 secondary outcomes
Number of participants with Adverse Events
Time frame: Up to Day 60
Number of participants with Serious Adverse Events
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 60
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 60
Number of participants with physical examination abnormalities
Time frame: Up to Day 60
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 60
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 26 Mar 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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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-986365, [14C] BMS-986365 and [14C] BMS-986409 + BMS-986410 in people with Healthy Volunteers, run by Celgene 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 5 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 26 Mar 2025. 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 concentration (Cmax) (time frame: Up to Day 60). The study lists 11 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 26 Mar 2025.