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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986166 + Oral contraceptive | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986166 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric means ratio of Cmax of NET | Geometric means ratio of maximum observed plasma concentration (Cmax) of norethindrone (NET) when administered with versus without BMS-986166 | Up to Day 26 |
| Geometric means ratio of Cmax of EE | Geometric means ratio of maximum observed plasma concentration (Cmax) of ethinyl estradiol (EE) when administered with versus without BMS-986166 | Up to Day 26 |
| Geometric means ratio of AUC(0-T) of NET | 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 | Up to Day 26 |
| Geometric means ratio of AUC(0-T) of EE | 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 | Up to Day 26 |
| Geometric means ratio of AUC(INF) of NET | 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 | Up to Day 26 |
| Geometric means ratio of AUC(INF) of EE | 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 | Up to Day 26 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials Global | Cypress | California | 90630 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Oral contraceptive |
| Drug |
Specified dose on specified days |
|
| 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 | PR interval is the time from the onset of the P wave to the start of the QRS complex | Up to Day 27 |
| Number of participants with clinically significant changes in ECG parameters: QRS | QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization | Up to Day 27 |
| Number of participants with clinically significant changes in ECG parameters: QT interval | The QT interval is the time from the start of the Q wave to the end of the T wave | Up to Day 27 |
| Number of participants with clinically significant changes in ECG parameters: QTcF | 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 | Up to Day 27 |
| Number of participants with physical examination abnormalities | Up to Day 27 |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| C000706608 | BMS-986166 |
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
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