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The purpose of this study is to evaluate the effect of itraconazole, phenytoin and gemfibrozil on the drug levels of BMS-986166 and its active metabolite BMT-121795. Participants will be randomly assigned to one of four groups and will remain in the study clinic for the duration of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986166 | Experimental |
| |
| BMS-986166 + Itraconazole | Experimental |
| |
| BMS-986166 + Phenytoin | Experimental |
| |
| BMS-986166 + Gemfibrozil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986166 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986166 | Up to Day 22 | |
| Cmax of BMT-121795 | Up to Day 22 | |
| Time of maximum observed plasma concentration (Tmax) of BMS-986166 | Up to Day 22 | |
| Tmax of BMT-121795 | Up to Day 22 | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986166 | Up to Day 22 | |
| AUC(0-T) of BMT-121795 | Up to Day 22 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))of BMS-986166 | Up to Day 22 | |
| AUC(INF) of BMT-121795 | Up to Day 22 | |
| Terminal plasma half-life (T-HALF) of BMS-986166 | Up to Day 22 | |
| T-HALF of BMT-121795 | Up to Day 22 | |
| Apparent total body clearance (CL/F) of BMS-986166 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Up to Day 55 | |
| Number of participants with Serious Adverse Events (SAEs) | Up to Day 55 | |
| Number of participants with physical examination abnormalities |
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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 |
|---|---|---|---|---|---|---|
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Itraconazole | Drug | Specified dose on specified days |
|
|
| Extended Phenytoin Sodium | Drug | Specified dose on specified days |
|
|
| Gemfibrozil | Drug | Specified dose on specified days |
|
|
| Up to Day 22 |
| Apparent volume of distribution (Vz/F) of BMS-986166 | Up to Day 22 |
| Ratio of BMT-121795 Cmax to parent Cmax corrected for molecular weight (MR_Cmax) | Up to Day 22 |
| Ratio of BMT-121795 AUC(0-T) to parent AUC(0-T) corrected for molecular weight (MR_AUC(0-T)) | Up to Day 22 |
| Ratio of BMT-121795 AUC(INF) to parent AUC(INF) corrected for molecular weight (MR_AUC(INF)) | Up to Day 22 |
| Up to Day 55 |
| Number of participants with clinically significant changes in vital signs: Body temperature | Up to Day 55 |
| Number of participants with clinically significant changes in vital signs: Respiratory rate | Up to Day 55 |
| Number of participants with clinically significant changes in vital signs: Blood pressure | Up to Day 55 |
| Number of participants with clinically significant changes in vital signs: Heart rate | Up to Day 55 |
| Number of participants with clinically significant changes in ECG parameters: PR interval | PR interval is the time from the onset of the P wave to the start of the QRS complex | Up to Day 55 |
| Number of participants with clinically significant changes in ECG parameters: QRS | QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization | Up to Day 55 |
| Number of participants with clinically significant changes in ECG parameters: QT interval | The QT interval is the time from the start of the Q wave to the end of the T wave | Up to Day 55 |
| Number of participants with clinically significant changes in ECG parameters: QTcF | QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave | Up to Day 55 |
| Number of participants with clinically significant changes in laboratory values: Hematology tests | Up to Day 55 |
| Number of participants with clinically significant changes in laboratory values: Chemistry tests | Up to Day 55 |
| Number of participants with clinically significant changes in laboratory values: Urinalysis | Up to Day 55 |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| C000706608 | BMS-986166 |
| D017964 | Itraconazole |
| D010672 | Phenytoin |
| D015248 | Gemfibrozil |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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