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The primary objective in this study is to assess if single doses of BMS-986104 that are safe, tolerable, and result in sufficient lymphopenia (50% to 70% reduction in absolute lymphocyte count) can be achieved without bradycardia or other adverse events in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel 1: BMS-986104 or Placebo | Experimental | BMS-986104 or Placebo single dose by mouth as specified |
|
| Panel 2: BMS-986104 or Placebo | Experimental | BMS-986104 or Placebo single dose by mouth as specified |
|
| Panel 3: BMS-986104 or Placebo | Experimental | BMS-986104 or Placebo single dose by mouth as specified |
|
| Panel 4: BMS-986104 or Placebo | Experimental | BMS-986104 or Placebo single dose by mouth as specified |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986104 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all adverse events (AEs) / serious adverse events (SAEs) | Up to 1 month post discharge | |
| Mean difference in ECG heart rate (HR) nadir values | Up to 4 days postdose | |
| Nadir absolute lymphocyte count (ALC) defined as the lowest ALC measured at any time after the dose | Up to 4 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability based on severity, investigator causality assessment and outcomes of all AEs (regardless of seriousness criteria), association between AEs and study drug exposure parameters, and physical examination | Up to 1 month post discharge | |
| Mean difference in ECG HR values in BMS-986104-treated versus placebo-treated healthy male subjects, identifying nadir ECG HR |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Inc. | Madison | Wisconsin | 53704 | United States |
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| Placebo | Drug |
|
| Day -1 up to 24h and Days 1-5 |
| Percent reduction in ECG HR | Day -1 up to 24h and Days 1-5 |
| Time to nadir ECG HR | Day -1 up to 24h and Days 1-5 |
| Maximum observed blood concentration (Cmax) of BMS-986104 | Up to Day 56 |
| Time of maximum observed blood concentration (Tmax) of BMS-986104 | Up to Day 56 |
| Terminal half-life (T-HALF) of BMS-986104 | Up to Day 56 |
| Area under the blood concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986104 | Up to Day 56 |
| Area under the blood concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986104 | Up to Day 56 |
| Apparent total clearance (CLT/F) of BMS-986104 | Up to Day 56 |
| Apparent volume of distribution of terminal phase (Vz/F) of BMS-986104 | Up to Day 56 |
| Metabolite to parent AUC(INF) ratio [MR_AUC(INF)] for both BMS-986104 and BMT-019434 | Up to Day 56 |
| Effects of single oral doses of BMS-986104 on the following ALC |
| Up to 4 days postdose |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000620393 | 1-amino-3-((R)-6-hexyl-5,6,7,8-tetrahydronaphthalen-2-yl)cyclopentyl)methanol |
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