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This is a study to investigate the experimental medication BMS-986165 in healthy participants in order to study the effects it has on electrocardiogram results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986165 Dose 1 oral administration | Experimental | BMS-986165 therapeutic single dose |
|
| BMS-986165 Dose 2 oral administration | Experimental | BMS-986165 supratherapeutic single dose |
|
| Moxifloxacin Dose 3 oral administration | Active Comparator | Moxifloxacin positive control single dose |
|
| Placebo Dose 4 oral administration | Placebo Comparator | Placebo single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG) | From baseline to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected change from baseline in corrected (Fridericia) QT Interval (QTcF) for moxifloxacin as determined by 12-lead ECG | From baseline to 5 days | |
| Heart rate (HR) as determined by 12-lead ECG | 5 days |
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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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences | 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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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin | Drug | Specified dose on specified days |
|
| Placebo | Other | Specified dose on specified days |
|
| QRS as determined by 12-lead ECG | 5 days |
| PR as determined by 12-lead ECG | 5 days |
| Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG | From baseline to 5 days |
| Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations | Up to 28 days |
| Incidence of adverse events (AE) | Up to 28 days |
| Incidence of serious adverse events (SAE) | Up to 28 days |
| Maximum observed concentration (Cmax) as determined by plasma concentration | 5 days |
| Time of maximum observed concentration (Tmax) as determined by plasma concentration | 5 days |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] as determined by plasma concentration | 5 days |
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration | 5 days |
| FDA Safety Alerts and Recalls | View source |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |