Not provided
Not provided
Not provided
Not provided
Not provided
Business objectives have changed
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 examine the effect of rifampin on the drug levels in blood and safety of BMS-986235, when taken by healthy participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986235 (Treatment A) | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of BMS-986235 | Day 1 | |
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 | Day 1 | |
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 | Day 1 | |
| Cmax of BMS-986235 with rifampin | Day 10 | |
| AUC(0-T) of BMS-986235 with rifampin | Day 10 | |
| AUC(INF) of BMS-986235 with rifampin | Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Nonserious Adverse Events (AEs) | Up to 46 days | |
| Incidence of Serious Adverse Events (SAEs) | Up to 74 days | |
| Incidence of AEs leading to discontinuation |
Not provided
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
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 | Salt Lake City | Utah | 84124 | United States |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
Not provided
Not provided
| ID | Term |
|---|---|
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rifampin (Treatment B) |
| Drug |
Specified dose on specified days |
|
| Up to 13 days |
| Incidence of clinically significant changes from baseline in physical examination findings | Up to 41 days |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 41 days |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 41 days |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 41 days |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 41 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters | Up to 41 days |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 41 days |
| Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests | Up to 41 days |
| Incidence of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2)) | Up to 41 days |
| FDA Safety Alerts and Recalls | View source |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |