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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Female Volunteers

Intervention / Treatment
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* Drug: BMS-986196
* Drug: Loestrin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986196 and Loestrin<br> | Drug: BMS-986196<br>* Specified dose on specified days<br>Drug: Loestrin<br>* Specified dose on specified days<br>* Other names: Ethinyl estradiol (EE) and norethindrone (NET);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, BMS-986196, Hormonal contraceptives, Ethinyl estradiol, Norethindrone, Female volunteers