A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05891262

Collaborator

(none)

Enrollment

Arm

2.8

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of BMS-986196 when coadministered with combined hormonal oral contraceptives (ethinyl estradiol [EE] and norethindrone [NET]) in healthy female participants.

Condition or Disease	Intervention/Treatment	Phase
Healthy Female Volunteers	Drug: BMS-986196 Drug: Loestrin	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Single-center, Open-label, Single-sequence Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 With Oral Contraceptives in Healthy Female Participants

Anticipated Study Start Date :

Jun 2, 2023

Anticipated Primary Completion Date :

Aug 25, 2023

Anticipated Study Completion Date :

Aug 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986196 and Loestrin	Drug: BMS-986196 Specified dose on specified days Drug: Loestrin Specified dose on specified days Other Names: Ethinyl estradiol (EE) and norethindrone (NET)

Arm

Intervention/Treatment

Experimental: BMS-986196 and Loestrin

Drug: BMS-986196

Specified dose on specified days

Drug: Loestrin

Specified dose on specified days

Other Names:

Ethinyl estradiol (EE) and norethindrone (NET)

Outcome Measures

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) [At Day 1 and Day 20]
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) [At Day 1 and Day 20]
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF]) [At Day 1 and Day 20]

Secondary Outcome Measures

Time of maximum observed plasma concentration (Tmax) [At Day 1 and Day 20]
Terminal half-life (T-HALF) [At Day 1 and Day 20]
Apparent total body clearance (CLT/F) [At Day 1 and Day 20]
Number of participants with Adverse Events (AEs) [Up to Day 49]
Number of participants with Serious AEs (SAEs) [Up to Day 49]
Number of participants with clinical laboratory abnormalities [Up to Day 49]
Number of participants with vital sign abnormalities [Up to Day 49]
Number of participants with electrocardiogram (ECG) abnormalities [Up to Day 49]
Number of participants with physical examination abnormalities [Up to Day 49]
Number of participants with any abnormal columbia-suicide severity rating scale (C-SSRS) [Up to Day 49]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participants must be genetically and hormonally female with intact ovarian function by medical history/menstrual cycles.
Body mass index between 18.0 and 35.0 kilograms/meter square (kg/m^2), inclusive, at screening.
Healthy female participants as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.

Exclusion Criteria:

Any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor Medical Monitor.
History of clinically significant heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, clinically significant ECG abnormalities, venous thromboembolism, or any congenital heart disease (as assessed by the investigator).
Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect drug absorption, distribution, metabolism and excretion (for example, bariatric procedure).
Any major surgery within 4 weeks of study intervention administration, including gastrointestinal surgery that could affect the absorption of study intervention.

Note: Other protocol-defined inclusion/exclusion criteria apply.