Healthy Female Volunteers
Conditions
Keywords
Pharmacokinetics, BMS-986196, Hormonal contraceptives, Ethinyl estradiol, Norethindrone, Female volunteers
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.
Interventions
DRUGBMS-986196
Specified dose on specified days
DRUGLoestrin
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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/
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Time of maximum observed plasma concentration (Tmax) | At Day 1 and Day 20 |
| 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 |
| Number of participants with vital sign abnormalities | Up to Day 49 |
| Terminal half-life (T-HALF) | At Day 1 and Day 20 |
| Apparent total body clearance (CLT/F) | At Day 1 and Day 20 |
Countries
United States
Outcome results
None listed