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To study the Pharmacokinetics (PK) parameters of montelukast, flurbiprofen, midazolam, digoxin, pravastatin, and MTX when coadministered with BMS-986142.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142 |
|
| Group 2 | Experimental | Methotrexate,Leucovorin and BMS-986142 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Days 1 through 10 | |
| Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration, AUC(0-T) | Days 1 through 10 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time, AUC(INF) | Days 1 through 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed plasma concentration (Tmax) | Days 1 through 10 | |
| Terminal plasma half-life (T-half) | Days 1 through 10 | |
| Apparent total body clearance (parents only), CLT/F |
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Inclusion Criteria:
Groups 1 and 2:
Group 1 only:
Group 2 only:
1. Healthy male subjects as determined by medical history, and clinical assessments.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas L Hunt, MD PhD | PPD Development, LP | Principal Investigator |
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|
| Methotrexate, Leucovorin and BMS-986142 | Drug |
|
|
| Days 1 through 10 |
| Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight | Days 1 through 10 |
| Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight | Days 1 through 10 |
| Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight | Days 1 through 10 |
| Trough observed plasma concentration (For BMS-986142 only) | Days 1 through 10 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| D005480 | Flurbiprofen |
| D008874 | Midazolam |
| D004077 | Digoxin |
| D017035 | Pravastatin |
| D008727 | Methotrexate |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| 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 |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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