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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Drospirenone/Ethinyl Estradiol

Drug: BMS-986278

Study type

Interventional

Funder types

Industry

Identifiers

NCT05985590

IM027-1013

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.