A Study to Characterize the Drug Levels of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential
- Registration Number
- NCT04934696
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to investigate the potential for a drug-drug interaction (DDI) when BMS-986166 and hormonal oral contraceptives are co-administered.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 25
- Nonpregnant, nonlactating Women of Childbearing Potential (WOCBP) who are healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations will be eligible to participate in the study.
- Body mass index (BMI) of 18.0 to 32.0 kg/m². BMI = weight (kg)/(height[m])² for participants.
- Participant must be 18 to 45 years of age, inclusive, at the time of signing the informed consent.
- Any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor Medical Monitor.
- History of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease.
- Any acute or chronic bacterial, fungal (except history of tinea pedis or ongoing onychomycosis will not be exclusionary) or viral infection within the last 3 months prior to screening, as well as any febrile illness or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening.
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description BMS-986166 + Oral contraceptive BMS-986166 - BMS-986166 + Oral contraceptive Oral contraceptive -
- Primary Outcome Measures
Name Time Method Geometric means ratio of Cmax of NET Up to Day 26 Geometric means ratio of maximum observed plasma concentration (Cmax) of norethindrone (NET) when administered with versus without BMS-986166
Geometric means ratio of Cmax of EE Up to Day 26 Geometric means ratio of maximum observed plasma concentration (Cmax) of ethinyl estradiol (EE) when administered with versus without BMS-986166
Geometric means ratio of AUC(0-T) of NET Up to Day 26 Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for NET when administered with versus without BMS-986166
Geometric means ratio of AUC(0-T) of EE Up to Day 26 Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for EE when administered with versus without BMS-986166
Geometric means ratio of AUC(INF) of NET Up to Day 26 Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for NET administered with versus without BMS-986166
Geometric means ratio of AUC(INF) of EE Up to Day 26 Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for EE when administered with versus without BMS-986166
- Secondary Outcome Measures
Name Time Method Tmax of BMT-121795 Up to Day 26 Cmax of BMS-986166 Up to Day 26 Cmax of BMT-121795 Up to Day 26 Time of maximum observed plasma concentration (Tmax) of BMS-986166 Up to Day 26 Area under the plasma concentration-time curve in one dosing interval (AUC(TAU)) of BMS-986166 Up to Day 26 AUC(TAU) of BMT-121795 Up to Day 26 Tmax of EE Up to Day 26 Tmax of NET Up to Day 26 Terminal plasma elimination phase half-life (T-HALF) of EE Up to Day 26 T-HALF of NET Up to Day 26 Apparent total clearance of drug from plasma after oral administration (CLT/F) of EE Up to Day 26 CLT/F of NET Up to Day 26 Apparent volume of distribution at terminal phase (Vz/F) of EE Up to Day 26 Vz/F of NET Up to Day 26 Number of participants with Adverse Events (AEs) Up to Day 37 Number of participants with Serious Adverse Events (SAEs) Up to Day 37 Number of participants with clinically significant changes in laboratory values: Hematology tests Up to Day 30 Number of participants with clinically significant changes in laboratory values: Chemistry tests Up to Day 30 Number of participants with clinically significant changes in laboratory values: Urinalysis Up to Day 30 Number of participants with clinically significant changes in vital signs: Body temperature Up to Day 27 Number of participants with clinically significant changes in vital signs: Respiratory rate Up to Day 27 Number of participants with clinically significant changes in vital signs: Blood pressure Up to Day 27 Number of participants with clinically significant changes in vital signs: Heart rate Up to Day 27 Number of participants with clinically significant changes in ECG parameters: PR interval Up to Day 27 PR interval is the time from the onset of the P wave to the start of the QRS complex
Number of participants with clinically significant changes in ECG parameters: QRS Up to Day 27 QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Number of participants with clinically significant changes in ECG parameters: QT interval Up to Day 27 The QT interval is the time from the start of the Q wave to the end of the T wave
Number of participants with clinically significant changes in ECG parameters: QTcF Up to Day 27 QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Number of participants with physical examination abnormalities Up to Day 27
Trial Locations
- Locations (1)
West Coast Clinical Trials Global
🇺🇸Cypress, California, United States