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This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986196 and/or Cocktail Probe Substrate Drugs | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986196 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 26 days | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 26 days | |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) | Up to 26 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed serum concentration (Tmax) | Up to 26 days | |
| Apparent terminal phase half-life (T-Half) | Up to 26 days | |
| Apparent total body clearance (CLT/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON plc | Millcreek | Utah | 84124 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | 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/disclosurecommitment.html
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| C093875 | montelukast |
| D005480 | Flurbiprofen |
| D009853 | Omeprazole |
| D008874 | Midazolam |
| D004077 | Digoxin |
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Caffeine |
| Drug |
Specified dose on specified days |
|
| Montelukast | Drug | Specified dose on specified days |
|
| Flurbiprofen | Drug | Specified dose on specified days |
|
| Omeprazole | Drug | Specified dose on specified days |
|
| Midazolam | Drug | Specified dose on specified days |
|
| Digoxin | Drug | Specified dose on specified days |
|
| Pravastatin | Drug | Specified dose on specified days |
|
| Up to 26 days |
| Number of participants with adverse events (AEs) | Up to 52 days |
| Number of participants with vital sign abnormalities | Up to 28 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 21 days |
| Number of participants with physical examination abnormalities | Up to 28 days |
| Number of participants with clinical laboratory abnormalities | Up to 28 days |
| Intensity of Suicidal Ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Up to 28 days |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |