A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (
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.
| Condition(s) | Healthy Volunteers |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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. |
| Ages | 18 Years to 60 Years |
| Sex | Male |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Celgene |
| Locations | Miami, Florida, United States |
| Start date | 2025-12-15 |
| NCT ID | NCT07242781 |
| Official listing | https://clinicaltrials.gov/study/NCT07242781 |