A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05985590
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 37
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment A: DRSP/EE Drospirenone/Ethinyl Estradiol - Treatment B: BMS-986278/DRSP/EE Drospirenone/Ethinyl Estradiol - Treatment B: BMS-986278/DRSP/EE BMS-986278 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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
Trial Locations
- Locations (1)
Local Institution - 0002
🇨🇦Québec, Quebec, Canada