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Business objectives have changed.
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This study will evaluate the effect of inhibitors, at steady state, on the drug levels, safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to be utilized in this study are fluconazole, bupropion, and itraconazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: BMS-986235+Fluconazole | Experimental |
| |
| Arm B: BMS-986235+ Bupropion | Experimental |
| |
| Arm C: BMS-986235+ Itraconazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluconazole | Drug | Specified Dose on Specified Days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole | Day 12 | |
| Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole | Day 12 | |
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole | Day 12 | |
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion | Day 13 | |
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with bupropion | Day 13 | |
| Maximum plasma concentration (Cmax) of BMS-986235 with bupropion | Day 13 | |
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with itraconazole | Day 9 | |
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole | Day 9 | |
| Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole | Day 9 | |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Nonserious Adverse Events (AEs) | Up to 49 days | |
| Incidence of Serious Adverse Events (SAEs) | Up to 77 days | |
| Incidence of AEs leading to discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Lenexa | Kansas | 66219 | United States | ||
| Local Institution |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| ID | Term |
|---|---|
| D015725 | Fluconazole |
| D016642 | Bupropion |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Bupropion |
| Drug |
Specified Dose on Specified Days |
|
| Itraconazole | Drug | Specified Dose on Specified Days |
|
| BMS-986235 | Drug | Specified Dose on Specified Days |
|
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 |
| Day 1 |
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 | Day 1 |
| Maximum plasma concentration (Cmax) of BMS-986235 | Day 1 |
| Up to 16 days |
| Number of clinically significant changes from baseline in vital signs: Body Temperature | Up to 44 days |
| Number of clinically significant changes from baseline in physical examinations | Up to 44 days |
| Number of clinically significant changes in clinical laboratory tests: Hematology | Up to 44 days |
| Number of clinically significant changes in clinical laboratory tests: Clinical Chemistry | Up to 44 days |
| Number of clinically significant changes in clinical laboratory tests: Coagulation | Up to 44 days |
| Number of clinically significant changes in clinical laboratory tests: Urinalysis | Up to 44 days |
| Number of clinically significant changes from baseline in vital signs: Respiratory Rate | Up to 44 days |
| Number of clinically significant changes from baseline in vital signs: Heart Rate | Up to 44 days |
| Number of clinically significant changes from baseline in vital signs:Blood Pressure | Up to 44 days |
| Number of clinically significant changes in electrocardiogram (ECG) | Up to 44 days |
| Number of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2)) | Up to 44 days |
| Salt Lake City |
| Utah |
| 84124 |
| United States |
| FDA Safety Alerts and Recalls | View source |
| D011427 |
| Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |