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The purpose of this study is to compare the taste, and the levels in blood plasma of different tablet formulations of BMS-986165 when taken by healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental |
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| Treatment Group 2 | Experimental |
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| Treatment Group 3 | Experimental |
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| Treatment Group 4 | Experimental |
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| Treatment Group 5 | Experimental |
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| Treatment Group 6 | Experimental |
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| Treatment Group 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 Tablet formulation 1 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) in plasma for BMS-986165 | Up to 26 days | |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 | Up to 26 days | |
| Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) in plasma for BMS-986165 | Up to 26 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 26 days | |
| Incidence of Serious Adverse Events (SAEs) | Up to 98 days | |
| Incidence of clinically significant changes in physical examination findings |
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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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences - Lenexa | Lenexa | Kansas | 66219 | 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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| Treatment Group 8 | Experimental |
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| Treatment Group 9 | Experimental |
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| Treatment Group 10 | Experimental |
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| BMS-986165 Tablet formulation 2 | Drug | Specified dose on specified days |
|
| Up to 68 days |
| Incidence of clinically significant changes in vital signs: Weight | Up to 68 days |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 68 days |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 68 days |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 68 days |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 68 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters | Up to 68 days |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 68 days |
| Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests | Up to 68 days |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Up to 68 days |
| FDA Safety Alerts and Recalls | View source |