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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003729-13 | EudraCT Number |
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The purpose of this study is to evaluate the effects of the experimental medication BMS-986256 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose | Experimental | Ascending single doses of BMS-986256 |
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| Multiple Dose | Experimental | Ascending multiple doses of BMS-986256 |
|
| Sequential Dose | Experimental | Sequential multiple doses of BMS-986256 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986256 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events (SAE) | Up to 46 days | |
| Number of deaths | Up to 46 days | |
| Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments | Up to 44 days | |
| Number of Adverse Events (AEs) leading to early discontinuation | Up to 44 days | |
| Maximum concentration (Cmax) | Up to 44 days | |
| Time of maximum concentration (Tmax) | Up to 44 days | |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)] | Up to 44 days | |
| Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] | Up to 44 days |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal elimination rate constant (kel) | Up to 44 days | |
| Terminal elimination half-life (T-half) | Up to 44 days | |
| Apparent oral clearance (CL/F) |
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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 could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States | ||
| PRA Health Science KK |
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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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| Placebo | Other | Specified dose on specified days |
|
| Up to 44 days |
| Metabolite ratio for AUC(INF) [MR(AUC[INF])] | Up to 44 days |
| Metabolite ratio of Cmax [MR(Cmax)] | Up to 44 days |
| Apparent volume of distribution at terminal phase (Vz/F) | Up to 44 days |
| Plasma concentration immediately prior to dosing (Ctrough) | Up to 44 days |
| Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)] | Up to 44 days |
| Accumulation ratio of Ctrough [AR(Ctrough)] | Up to 44 days |
| Accumulation ratio of AUC(TAU) [AR(AUC[TAU])] | Up to 44 days |
| Accumulation ratio of Cmax [AR(Cmax)] | Up to 44 days |
| Metabolite ratio for AUC(TAU) [MR(AUC[TAU])] | Up to 44 days |
| Lenexa |
| Kansas |
| 66219 |
| United States |
| FDA Safety Alerts and Recalls | View source |