A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of Multiple Doses of BMS-986278 on the Pharmacokinetics of Combined Oral Contraceptives (Drospirenone/Ethinyl Estradiol) in Healthy Female Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: BMS-986278
* Drug: Drospirenone/Ethinyl Estradiol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index between 18.0 and 32.0 kilograms/meter square (kg/m^2), inclusive. Body weight ≥ 45 kg. Healthy females, as determined by physical examination and clinical laboratory assessments (including chemistry, hematology, coagulation, and urinalysis) within the normal range at the screening visit and on Day -1, as applicable. Exclusion Criteria: Any significant acute or chronic medical illness. Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (eg, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed (12 months prior to screening). Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, especially eye issues, as determined by the investigator. Note: Other protocol-defined inclusion/exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A: DRSP/EE<br> | Drug: Drospirenone/Ethinyl Estradiol<br>* Specified dose on specified days<br>|
| Experimental: Treatment B: BMS-986278/DRSP/EE<br> | Drug: BMS-986278<br>* Specified dose on specified days<br>Drug: Drospirenone/Ethinyl Estradiol<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, BMS-986278, Hormonal contraceptives, Ethinyl estradiol, Drospirenone, Pulmonary fibrosis