Healthy ParticipantsPhase 1NCT06417229
Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants
A Phase 1 study testing BMS-986365 and Rabeprazole in people with Healthy Participants, run by Celgene at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants. 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 Participants
- What is being tested?
- BMS-986365 and Rabeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to 19 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 adult male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, ECGs, echocardiogram, or clinical laboratory assessments as determined by the investigator.
- Body mass index (BMI) of 18.0 to 32.0 kg/m^2, inclusive.
Who cannot join
- Any significant acute or chronic illness.
- Prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.
- History of allergy/hypersensitivity to any component (including excipients) of BMS-986365 study interventions 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, Two-part, Open-label Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986365, Food and Proton Pump Inhibitor Effects, and Relative Bioavailability of BMS-986365 Capsule Compared to Tablet Formulation in Healthy Adult Male Participants
The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.
- Conditions
- Healthy Participants
- Being tested
- BMS-986365, Rabeprazole
- Keywords
- BMS-986365, Pharmacokinetics, Relative Bioavailability, Healthy Male Volunteers, CC-94676, Food Effect, Proton Pump Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986365Drug
Also called CC-94676
Specified dose on specified days
RabeprazoleDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort 1 BMS-986365 Dose 1 | Experimental | Not described Receives: Drug: BMS-986365 |
| Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1 | Experimental | Not described Receives: Drug: BMS-986365 |
| Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2 | Experimental | Not described Receives: Drug: BMS-986365 |
| Part 1: Cohort 3 BMS-986365 Dose 4 | Experimental | Not described Receives: Drug: BMS-986365 |
| Part 1: Cohort 6 BMS-986365 Dose 5 | Experimental | Not described Receives: Drug: BMS-986365 |
| Part 1: Cohort 7 BMS-986365 Dose 6 | Experimental | Not described Receives: Drug: BMS-986365 |
| Part 1: Cohort 8 BMS-986365 Dose 7 | Experimental | Not described Receives: Drug: BMS-986365 |
| Part 1: Cohort 9 BMS-986365 Dose 8 | Experimental | Not described Receives: Drug: BMS-986365 |
| Part 2: Cohort 4 BMS-986365 Dose 9 Fasted | Experimental | Not described Receives: Drug: BMS-986365 |
| Part 2: Cohort 4 BMS-986365 Dose 10 Fed | Experimental | Not described Receives: Drug: BMS-986365 |
| Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365 | Experimental | Not described Receives: Drug: BMS-986365; Drug: Rabeprazole |
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 75
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Measured: Up to Day 75
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Measured: Up to Day 75
Secondary outcomes (7)
To assess the bioavailability of BMS-986365 experimental formulation relative to the reference formulation
Measured: Up to Day 75
Incidence of adverse events (AE)
Measured: Up to Day 75
Incidence of serious adverse events (SAE)
Measured: Up to Day 75
Number of participants with physical examination abnormalities
Measured: Up to Day 75
Number of participants with vital sign abnormalities
Measured: Up to Day 75
Number of participants with clinical laboratory abnormalities
Measured: Up to Day 75
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 75
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start28 May 2024
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 102 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
- NCT06417229
- Sponsor's protocol ID
- CA228-1011
- Status last verified
- Mar 2025
- First submitted
- 13 May 2024
- Last updated
- 6 Mar 2025
- 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 Myer 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-part, Open-label Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986365, Food and Proton Pump Inhibitor Effects, and Relative Bioavailability of BMS-986365 Capsule Compared to Tablet Formulation in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT06417229
- Acronym / sponsor ID
- CA228-1011
- Conditions
- Healthy Participants
- Keywords
- BMS-986365, Pharmacokinetics, Relative Bioavailability, Healthy Male Volunteers, CC-94676, Food Effect, Proton Pump Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 16 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 purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort 1 BMS-986365 Dose 1 | Experimental | Drug: BMS-986365 |
| Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1 | Experimental | Drug: BMS-986365 |
| Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2 | Experimental | Drug: BMS-986365 |
| Part 1: Cohort 3 BMS-986365 Dose 4 | Experimental | Drug: BMS-986365 |
| Part 1: Cohort 6 BMS-986365 Dose 5 | Experimental | Drug: BMS-986365 |
| Part 1: Cohort 7 BMS-986365 Dose 6 | Experimental | Drug: BMS-986365 |
| Part 1: Cohort 8 BMS-986365 Dose 7 | Experimental | Drug: BMS-986365 |
| Part 1: Cohort 9 BMS-986365 Dose 8 | Experimental | Drug: BMS-986365 |
| Part 2: Cohort 4 BMS-986365 Dose 9 Fasted | Experimental | Drug: BMS-986365 |
| Part 2: Cohort 4 BMS-986365 Dose 10 Fed | Experimental | Drug: BMS-986365 |
| Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365 | Experimental | Drug: BMS-986365, Drug: Rabeprazole |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, ECGs, echocardiogram, or clinical laboratory assessments as determined by the investigator.
- Body mass index (BMI) of 18.0 to 32.0 kg/m^2, inclusive.
Key exclusion criteria (4 listed)
- Any significant acute or chronic illness.
- Prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.
- History of allergy/hypersensitivity to any component (including excipients) of BMS-986365 study interventions 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-986365Also: CC-94676Specified dose on specified days | Drug | Part 1: Cohort 1 BMS-986365 Dose 1, Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1, Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2, Part 1: Cohort 3 BMS-986365 Dose 4, Part 1: Cohort 6 BMS-986365 Dose 5, Part 1: Cohort 7 BMS-986365 Dose 6, Part 1: Cohort 8 BMS-986365 Dose 7, Part 1: Cohort 9 BMS-986365 Dose 8, Part 2: Cohort 4 BMS-986365 Dose 10 Fed, Part 2: Cohort 4 BMS-986365 Dose 9 Fasted, Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365 |
| RabeprazoleSpecified dose on specified days | Drug | Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365 |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 75
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Time frame: Up to Day 75
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Up to Day 75
7 secondary outcomes
To assess the bioavailability of BMS-986365 experimental formulation relative to the reference formulation
Time frame: Up to Day 75
Incidence of adverse events (AE)
Time frame: Up to Day 75
Incidence of serious adverse events (SAE)
Time frame: Up to Day 75
Number of participants with physical examination abnormalities
Time frame: Up to Day 75
Number of participants with vital sign abnormalities
Time frame: Up to Day 75
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 75
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 75
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 6 Mar 2025.
- 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 Myer 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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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 and Rabeprazole in people with Healthy Participants, 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 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 6 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 plasma concentration (Cmax) (time frame: Up to Day 75). The study lists 3 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 6 Mar 2025.