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The purpose of the study is to assess the effects of BMS-986278 on Drospirenone (DRSP) and Ethinyl Estradiol (EE) when administered as a combined oral contraceptive in healthy female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: DRSP/EE | Experimental |
| |
| Treatment B: BMS-986278/DRSP/EE | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986278 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Predose and post-dose up to Day 28 | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Predose and post-dose up to Day 28 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF]) | Predose and post-dose up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed concentration (Tmax) | Predose and post-dose up to Day 28 | |
| Terminal half-life (T-Half) | Predose and post-dose up to Day 28 | |
| Apparent total body clearance after extravascular administration (CL/F) |
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Inclusion Criteria:
Exclusion Criteria:
Note: 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 |
|---|---|---|---|---|---|---|
| Local Institution - 0002 | Québec | Quebec | G1P 0A2 | Canada |
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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/disclosure-commitment.html
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| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
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| ID | Term |
|---|---|
| C534342 | drospirenone and ethinyl estradiol combination |
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| Drospirenone/Ethinyl Estradiol |
| Drug |
Specified dose on specified days |
|
| Predose and post-dose up to Day 28 |
| Number of Participants with Adverse Events (AEs) | Up to Day 53 |
| Number of Participants with Serious AEs (SAEs) | Up to Day 53 |
| Number of Participants with AEs leading to discontinuation | Up to Day 53 |
| Number of Participants with Physical Examination Abnormalities | Up to Day 28 |
| Number of Participants with Vital Sign Abnormalities | Up to Day 28 |
| Number of Participants with Electrocardiogram (ECG) Abnormalities | Up to Day 28 |
| Number of Participants with Clinical Laboratory Abnormalities | Up to Day 27 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |