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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05985590

Collaborator

(none)

Enrollment

Arms

2.8

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: BMS-986278 Drug: Drospirenone/Ethinyl Estradiol	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 15, 2023

Anticipated Primary Completion Date :

Nov 7, 2023

Anticipated Study Completion Date :

Nov 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A: DRSP/EE	Drug: Drospirenone/Ethinyl Estradiol Specified dose on specified days
Experimental: Treatment B: BMS-986278/DRSP/EE	Drug: BMS-986278 Specified dose on specified days Drug: Drospirenone/Ethinyl Estradiol Specified dose on specified days

Arm

Intervention/Treatment

Experimental: Treatment A: DRSP/EE

Drug: Drospirenone/Ethinyl Estradiol

Specified dose on specified days

Experimental: Treatment B: BMS-986278/DRSP/EE

Drug: BMS-986278

Specified dose on specified days

Drug: Drospirenone/Ethinyl Estradiol

Specified dose on specified days

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

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.