Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, single-sequence, drug-drug interaction study in healthy male and female subjects. There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may increase the exposure of montelukast, flurbiprofen, and digoxin.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Sequence, A B C | Experimental | Treatment A: Single oral dose of montelukast, flurbiprofen, and digoxin on Day 1 Treatment B: BMS-986020 orally twice daily (BID) on Day 8 through Day 10 Treatment C: BMS-986020 orally BID, single oral dose of montelukast, flurbiprofen, and digoxin on Day 11; BMS-986020 BID on Day 12 through Day 17 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986020 | Drug |
| ||
| Montelukast |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters (maximum observed plasma concentration, area under the concentration-time curve) for montelukast, flurbiprofen, and digoxin | Pharmacokinetic endpoints for montelukast, flurbiprofen, and digoxin with and without BMS-986020 | Predose and up to 168 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Additional pharmacokinetic parameters for montelukast, flurbiprofen, and digoxin. | Additional pharmacokinetic parameters for montelukast, flurbiprofen, digoxin, and with and without BMS-986020 | Predose and up to 168 hour post dose |
| Safety |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined exclusion criteria could apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emanuel DeNoia, MD | ICON Development Solutions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Discoveries, LLC d/b/a ICON Development Solutions | San Antonio | Texas | 78209 | United States |
Not provided
| ID | Term |
|---|---|
| C093875 | montelukast |
| D005480 | Flurbiprofen |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Flurbiprofen | Drug |
|
| Digoxin | Drug |
|
Collection of adverse events and other physical parameters to assess safety
| From dosing (Day 1) to Day 21 |
| D001713 |
| Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |