Effect of itraconazole and rifampin on BMS-986365 levels in healthy men
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
This trial will test whether taking itraconazole (an antifungal) or rifampin (an antibiotic) changes blood levels of the experimental drug BMS-986365 in healthy adult men.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Male |
| Sponsor | Celgene Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07242781 on ClinicalTrials.gov |
What this trial studies
This Phase 1 pharmacokinetic interaction study will enroll healthy adult male volunteers to measure BMS-986365 blood concentrations when given alone and when coadministered with itraconazole or rifampin. Participants will receive BMS-986365 in separate dosing periods with controlled administration of the interacting drugs and serial blood sampling to profile drug concentrations over time. Safety monitoring will include vital signs, 12-lead ECG, transthoracic echocardiogram, and laboratory assessments. The study aims to quantify how inhibition or induction of drug-metabolizing pathways alters exposure to BMS-986365.
Who should consider this trial
Good fit: Ideal candidates are healthy adult males with BMI 18.0–32.0 kg/m2 who have no significant or chronic illnesses and normal cardiac, laboratory, and physical exam findings.
Not a fit: Women, people with chronic or significant illnesses, or patients seeking therapeutic benefit from BMS-986365 are unlikely to receive direct clinical benefit from participation.
Why it matters
Potential benefit: If successful, the results will help clinicians know whether common medications like itraconazole or rifampin alter BMS-986365 levels so they can recommend safe dosing or avoid harmful interactions.
How similar studies have performed: Using itraconazole (a CYP3A inhibitor) and rifampin (a CYP inducer) to probe drug-drug interactions is a standard, well-established approach that has reliably predicted clinical interaction effects for many drugs.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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. Exclusion Criteria * 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.
Where this trial is running
Miami, Florida
- Syneos Health Clinic — Miami, Florida, United States (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.