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

• Status: Not yet recruiting
• Trial end date: 2023-08-25
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Estradiol; Ethinyl Estradiol; Norethindrone; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination

Criteria

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.