Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004300-38 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the relative bioavailability of branebrutinib tablet formulation relative to the capsule formulation in order to identify doses that would provide exposures similar to the capsule formulation over the dose range that may be used in future clinical studies, evaluate the effect of food on the bioavailability of branebrutinib from a tablet formulation at a dose projected to provide similar pharmacokinetics (PK) as the 9 mg capsule formulation, and evaluate the safety and the PK of multiple oral dose of tablet formulation of branebrutinib in healthy participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Treatment A | Experimental |
| |
| Part 1 Treatment B | Experimental |
| |
| Part 1 Treatment C | Experimental |
| |
| Part 1 Treatment D | Experimental |
| |
| Part 2 Treatment A | Experimental |
| |
| Part 2 Treatment B | Experimental |
| |
| Part 2 Treatment C | Experimental |
| |
| Part 3 Treatment A |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Branebrutinib | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 14 | |
| Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Day 14 | |
| AUC from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 14 | |
| Number of participants with adverse events (AEs) | Up to 30 days post last scheduled visit | |
| Number of participants with vital sign abnormalities | Up to Day 14 | |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 14 | |
| Number of participants with physical examination abnormalities | Up to Day 14 | |
| Number of participants with clinical laboratory abnormalities | Up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean ratio of Cmax | Up to Day 17 | |
| Geometric mean ratio of AUC(0-T) | Up to Day 17 | |
| Geometric mean ratio of AUC(INF) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Miami | Florida | 33136 | United States |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Part 3 Treatment B | Placebo Comparator |
|
|
| Placebo | Drug | Specified Dose on specified days |
|
| Up to Day 17 |
| Time of maximum observed plasma concentration (Tmax) | Up to Day 17 |
| Apparent total body clearance (CLT/F) | Up to Day 14 |
| Apparent volume of distribution (Vz/F) | Up to Day 14 |
| Number of participants with AEs | Up to 30 days post last scheduled visit |
| Number of participants with vital sign abnormalities | Up to Day 14 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 14 |
| Number of participants with physical examination abnormalities | Up to Day 14 |
| Number of participants with clinical laboratory abnormalities | Up to Day 14 |
| ID | Term |
|---|---|
| C000710709 | branebrutinib |
Not provided
Not provided
Not provided