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

• Status: Completed
• Trial end date: 2023-12-11
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Drospirenone; Drospirenone and ethinyl estradiol combination; Estradiol; Ethinyl Estradiol

Criteria

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.