Status:
COMPLETED
A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Volunteers
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2023
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT05985590
Start Date
August 18 2023
End Date
December 11 2023
Last Update
January 24 2024
Active Locations (1)
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1
Local Institution - 0002
Québec, Quebec, Canada, G1P 0A2