A Study to Characterize the Drug Levels of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BMS-986166 + Oral contraceptive
|
Drug: BMS-986166
Specified dose on specified days
Drug: Oral contraceptive
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
- Tmax of BMT-121795 [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]
Eligibility Criteria
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion Criteria:
-
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.
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Participant must be 18 to 45 years of age, inclusive, at the time of signing the informed consent.
Exclusion Criteria:
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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.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | West Coast Clinical Trials Global | Cypress | California | United States | 90630 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.- IM018-006