Healthy VolunteersPhase 1NCT07242781
A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants
A Phase 1 study testing BMS-986365, Itraconazole and Rifampin in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of Itraconazole and Rifampin on the drug levels of AR-LDD (BMS-986365) in healthy adult 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 Volunteers
- What is being tested?
- BMS-986365, Itraconazole and Rifampin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 21 Apr 2026
- 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
- Participants must be male, at the time of signing the Informed Consent Form (ICF), have a Body Mass Index (BMI) of 18.0 to 32.0 kg/m2; and healthy as determined by medical history, PE, vital signs, 12-lead ECG, transthoracic echocardiogram (TTE) and clinical laboratory assessments.
Who cannot join
- Participants must not have any significant or chronic illness.
- Participants must not have a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.
- 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, 2-part, Fixed-sequence, Crossover Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics of AR-LDD (BMS-986365) in Healthy Adult Male Participants
The purpose of this study is to evaluate the effect of Itraconazole and Rifampin on the drug levels of AR-LDD (BMS-986365) in healthy adult male participants.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986365, Itraconazole, Rifampin
- Keywords
- Healthy male volunteers, BMS-986365, CC-94676, Itraconazole, Rifampin, Pharmacokinetics, Crossover, Open-label
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986365Drug
Also called AR-LDD, CC-94676
Specified dose on specified days
ItraconazoleDrug
Also called SPORANOX®
Specified dose on specified days
RifampinDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A (Safety Lead-in Group) | Experimental | Not described Receives: Drug: BMS-986365; Drug: Itraconazole |
| Part A, Period 1 | Experimental | Not described Receives: Drug: BMS-986365 |
| Part A, Period 2 | Experimental | Not described Receives: Drug: BMS-986365; Drug: Itraconazole |
| Part B, Period 1 | Experimental | Not described Receives: Drug: BMS-986365 |
| Part B, Period 2 | Experimental | Not described Receives: Drug: BMS-986365; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Maximum Observed Plasma Concentration (Cmax) of BMS-986365
Measured: Up to approximately Day 32
Part A: Cmax of BMS-986365 Without Itraconazole
Measured: Up to approximately Day 32
Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986365 With Itraconazole
Measured: Up to approximately Day 32
Part A: AUC(0-T) of BMS-986365 Without Itraconazole
Measured: Up to approximately Day 32
Part A: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986365
Measured: Up to approximately Day 32
Part A: AUC(INF) of BMS-986365 Without Itraconazole
Measured: Up to approximately Day 32
Part B: Cmax of BMS-986365 With Rifampin
Measured: Up to approximately Day 37
Part B: Cmax of BMS-986365 Without Rifampin
Measured: Up to approximately Day 37
Part B: AUC(INF) of BMS-986365 With Rifampin
Measured: Up to approximately Day 37
Part B: AUC(INF) of BMS-986365 Without Rifampin
Measured: Up to approximately Day 37
Part B: AUC(0-T) of BMS-986365 With Rifampin
Measured: Up to approximately Day 37
Part B: AUC(0-T) of BMS-986365 Without Rifampin
Measured: Up to approximately Day 37
Secondary outcomes (14)
Number of Participants With Adverse Events (AEs)
Measured: Up to approximately Day 89
Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to approximately Day 89
Number of Participants With AEs Leading to Drug/Study Discontinuation
Measured: Up to approximately Day 89
Number of Participants With Clinically Significant Vital Sign Measurements
Measured: Up to approximately Day 77
Number of Participants With Clinically Significant Laboratory Safety Tests
Laboratory safety tests include hematology, chemistry, and urinalysis.
Measured: Up to approximately Day 77
Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
Measured: Up to approximately Day 77
Number of Participants With Clinically Significant Physical Examination (PE) Abnormalities
Measured: Up to approximately Day 77
Change From Baseline of Corrected QT Interval (QTc) Post Dose of BMS-986365
Measured: Up to approximately Day 77
Part A: Change From Baseline of QTc Post Dose of BMS-986365 With Itaconazole
Measured: Up to approximately Day 72
Part B: Change From Baseline of QTc Post Dose of BMS-986365 With Rifampin
Measured: Up to approximately Day 77
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986365
Measured: Up to approximately Day 77
Apparent Terminal Plasma Half-life (T-HALF) of BMS-986365
Measured: Up to approximately Day 77
Apparent Total Body Clearance (CLT/F) of BMS-986365
Measured: Up to approximately Day 77
Apparent Volume of Distribution of Terminal Phase (Vz/F) of BMS-986365
Measured: Up to approximately Day 77
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Dec 2025
- Primary completion9 Apr 2026
- Study completion21 Apr 2026
Why it stopped: Business objectives have changed
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT07242781
- Sponsor's protocol ID
- CA071-1006
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.html
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, 2-part, Fixed-sequence, Crossover Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics of AR-LDD (BMS-986365) in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT07242781
- Acronym / sponsor ID
- CA071-1006
- Conditions
- Healthy Volunteers
- Keywords
- Healthy male volunteers, BMS-986365, CC-94676, Itraconazole, Rifampin, Pharmacokinetics, Crossover, Open-label
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 21 Nov 2025 (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 effect of Itraconazole and Rifampin on the drug levels of AR-LDD (BMS-986365) in healthy adult male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A (Safety Lead-in Group) | Experimental | Drug: BMS-986365, Drug: Itraconazole |
| Part A, Period 1 | Experimental | Drug: BMS-986365 |
| Part A, Period 2 | Experimental | Drug: BMS-986365, Drug: Itraconazole |
| Part B, Period 1 | Experimental | Drug: BMS-986365 |
| Part B, Period 2 | Experimental | Drug: BMS-986365, Drug: Rifampin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants must be male, at the time of signing the Informed Consent Form (ICF), have a Body Mass Index (BMI) of 18.0 to 32.0 kg/m2; and healthy as determined by medical history, PE, vital signs, 12-lead ECG, transthoracic echocardiogram (TTE) and clinical laboratory assessments.
Key exclusion criteria (3 listed)
- Participants must not have any significant or chronic illness.
- Participants must not have a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.
- 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: AR-LDD, CC-94676Specified dose on specified days | Drug | Part A (Safety Lead-in Group), Part A, Period 1, Part A, Period 2, Part B, Period 1, Part B, Period 2 |
| ItraconazoleAlso: SPORANOX®Specified dose on specified days | Drug | Part A (Safety Lead-in Group), Part A, Period 2 |
| RifampinSpecified dose on specified days | Drug | Part B, Period 2 |
Primary outcome
Part A: Maximum Observed Plasma Concentration (Cmax) of BMS-986365
Time frame: Up to approximately Day 32
Part A: Cmax of BMS-986365 Without Itraconazole
Time frame: Up to approximately Day 32
Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986365 With Itraconazole
Time frame: Up to approximately Day 32
Part A: AUC(0-T) of BMS-986365 Without Itraconazole
Time frame: Up to approximately Day 32
Part A: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986365
Time frame: Up to approximately Day 32
Part A: AUC(INF) of BMS-986365 Without Itraconazole
Time frame: Up to approximately Day 32
Part B: Cmax of BMS-986365 With Rifampin
Time frame: Up to approximately Day 37
Part B: Cmax of BMS-986365 Without Rifampin
Time frame: Up to approximately Day 37
Part B: AUC(INF) of BMS-986365 With Rifampin
Time frame: Up to approximately Day 37
Part B: AUC(INF) of BMS-986365 Without Rifampin
Time frame: Up to approximately Day 37
Part B: AUC(0-T) of BMS-986365 With Rifampin
Time frame: Up to approximately Day 37
Part B: AUC(0-T) of BMS-986365 Without Rifampin
Time frame: Up to approximately Day 37
14 secondary outcomes
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately Day 89
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to approximately Day 89
Number of Participants With AEs Leading to Drug/Study Discontinuation
Time frame: Up to approximately Day 89
Number of Participants With Clinically Significant Vital Sign Measurements
Time frame: Up to approximately Day 77
Number of Participants With Clinically Significant Laboratory Safety Tests
Time frame: Up to approximately Day 77
Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
Time frame: Up to approximately Day 77
Number of Participants With Clinically Significant Physical Examination (PE) Abnormalities
Time frame: Up to approximately Day 77
Change From Baseline of Corrected QT Interval (QTc) Post Dose of BMS-986365
Time frame: Up to approximately Day 77
Part A: Change From Baseline of QTc Post Dose of BMS-986365 With Itaconazole
Time frame: Up to approximately Day 72
Part B: Change From Baseline of QTc Post Dose of BMS-986365 With Rifampin
Time frame: Up to approximately Day 77
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986365
Time frame: Up to approximately Day 77
Apparent Terminal Plasma Half-life (T-HALF) of BMS-986365
Time frame: Up to approximately Day 77
Apparent Total Body Clearance (CLT/F) of BMS-986365
Time frame: Up to approximately Day 77
Apparent Volume of Distribution of Terminal Phase (Vz/F) of BMS-986365
Time frame: Up to approximately Day 77
Results and safety
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.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, Itraconazole and Rifampin 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Jul 2026. 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 was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
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?
Part A: Maximum Observed Plasma Concentration (Cmax) of BMS-986365 (time frame: Up to approximately Day 32). The study lists 12 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 20 Jul 2026.