NCT05985590CompletedPhase 1
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
Bristol-Myers Squibb1 site in 1 country37 target enrollmentStarted: August 18, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Maximum observed plasma concentration (Cmax)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Treatment A: DRSP/EE
Experimental
Intervention: Drospirenone/Ethinyl Estradiol (Drug)
Treatment B: BMS-986278/DRSP/EE
Experimental
Intervention: BMS-986278 (Drug)
Treatment B: BMS-986278/DRSP/EE
Experimental
Intervention: Drospirenone/Ethinyl Estradiol (Drug)
Outcomes
Primary Outcomes
Maximum observed plasma concentration (Cmax)
Time Frame: 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])
Time Frame: Predose and post-dose up to Day 28
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
Time Frame: Predose and post-dose up to Day 28
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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