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The purpose of this study is to examine the interaction of branebrutinib with rosuvastatin. Rosuvastatin is a substrate of the breast cancer resistance protein (BCRP) transporter, which has a drug level profile that can be markedly altered by coadministration of known inhibitors of the BCRP transporter. With widespread use of statins as cholesterol-lowering agents, rosuvastatin is also a likely concomitant drug for participants who would potentially be treated with branebrutinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period A: Rosuvastatin | Experimental |
| |
| Period B: Branebrutinib | Experimental |
| |
| Period C: Branebrutinib + Rosuvastatin and Branebrutinib | Experimental |
| |
| Period D: Branebrutinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of rosuvastatin | Up to 6 days | |
| Maximum observed plasma concentration (Cmax) of rosuvastatin when coadministered with branebrutinib | Day 13 | |
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin | Up to 6 days | |
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin when coadministered with branebrutinib | Day 13 | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin | Up to 6 days | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin when coadministered with branebrutinib | Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 33 days | |
| Incidence of Serious Adverse Events (SAEs) | Up to 77 days | |
| Incidence of AEs leading to discontinuation |
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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 |
|---|---|---|---|---|---|---|
| ICON (LPRA) - Salt Lake | Salt Lake City | Utah | 84124 | 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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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| C000710709 | branebrutinib |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Branebrutinib | Drug | Specified dose on specified days |
|
| Up to 33 days |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 54 days |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 54 days |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 54 days |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 54 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | PR interval: The time from the onset of the P wave to the start of the QRS complex | Up to 54 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval | QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization | Up to 54 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | QT interval: Measured from the beginning of the QRS complex to the end of the T wave | Up to 54 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval | QTcF interval: Corrected QT interval using Fridericia's formula (QTcF) | Up to 54 days |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 53 days |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Up to 53 days |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Up to 53 days |
| FDA Safety Alerts and Recalls | View source |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |