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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A (Safety Lead-in Group) | Experimental |
| |
| Part A, Period 1 | Experimental |
| |
| Part A, Period 2 | Experimental |
| |
| Part B, Period 1 | Experimental |
| |
| Part B, Period 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986365 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Maximum Observed Plasma Concentration (Cmax) of BMS-986365 | Up to approximately Day 32 | |
| Part A: Cmax of BMS-986365 Without Itraconazole | 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 | Up to approximately Day 32 | |
| Part A: AUC(0-T) of BMS-986365 Without Itraconazole | 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 | Up to approximately Day 32 | |
| Part A: AUC(INF) of BMS-986365 Without Itraconazole | Up to approximately Day 32 | |
| Part B: Cmax of BMS-986365 With Rifampin | Up to approximately Day 37 | |
| Part B: Cmax of BMS-986365 Without Rifampin | Up to approximately Day 37 | |
| Part B: AUC(INF) of BMS-986365 With Rifampin | Up to approximately Day 37 | |
| Part B: AUC(INF) of BMS-986365 Without Rifampin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to approximately Day 89 | |
| Number of Participants With Serious Adverse Events (SAEs) | Up to approximately Day 89 | |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain the NCT# and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syneos Health Clinic | Recruiting | Miami | Florida | 33136 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
See plan description
See plan description
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Itraconazole | Drug | Specified dose on specified days |
|
|
| Rifampin | Drug | Specified dose on specified days |
|
| Up to approximately Day 37 |
| Part B: AUC(0-T) of BMS-986365 With Rifampin | Up to approximately Day 37 |
| Part B: AUC(0-T) of BMS-986365 Without Rifampin | Up to approximately Day 37 |
| Number of Participants With AEs Leading to Drug/Study Discontinuation |
| Up to approximately Day 89 |
| Number of Participants With Clinically Significant Vital Sign Measurements | Up to approximately Day 77 |
| Number of Participants With Clinically Significant Laboratory Safety Tests | Laboratory safety tests include hematology, chemistry, and urinalysis. | Up to approximately Day 77 |
| Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities | Up to approximately Day 77 |
| Number of Participants With Clinically Significant Physical Examination (PE) Abnormalities | Up to approximately Day 77 |
| Change From Baseline of Corrected QT Interval (QTc) Post Dose of BMS-986365 | Up to approximately Day 77 |
| Part A: Change From Baseline of QTc Post Dose of BMS-986365 With Itaconazole | Up to approximately Day 72 |
| Part B: Change From Baseline of QTc Post Dose of BMS-986365 With Rifampin | Up to approximately Day 77 |
| Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986365 | Up to approximately Day 77 |
| Apparent Terminal Plasma Half-life (T-HALF) of BMS-986365 | Up to approximately Day 77 |
| Apparent Total Body Clearance (CLT/F) of BMS-986365 | Up to approximately Day 77 |
| Apparent Volume of Distribution of Terminal Phase (Vz/F) of BMS-986365 | Up to approximately Day 77 |
| D010879 |
| Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |