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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, 2-cycle, multiple-dose, single-sequence study in women of child-bearing potential. The primary objective is to assess the effect of BMS-986142 on the pharmacokinetics (PK) of Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily single dose of OC containing EE and NET | Experimental | Daily single dose of OC Containing EE and NET alone. |
|
| Daily single dose of OC in combination with BMS-986142 | Experimental | Daily single dose of OC containing EE and NET in combination with BMS-986142. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OC containing EE and NET | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of EE and NET | Cycle 1 Day 21 to Cycle 2 Day 22 (30 days) | |
| Area under the concentration-time curve (AUC) of EE and NET | Cycle 1 Day 21 to Cycle 2 Day 22 (30 days) | |
| Area under the concentration-time curve over the dosing interval [AUC (TAU)] of EE and NET | Cycle 1 Day 21 to Cycle 2 Day 22 (30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death. | Cycle 1 Day 1 to Cycle 2 Day 25; For SAEs up to 30 days post discontinuation of dosing or participation. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Research Associates | Miami | Florida | 33143 | United States | ||
| Covance Evansville Clinical Research Unit |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BMS-986142 |
| Drug |
|
| Evansville |
| Indiana |
| 47710 |
| United States |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided