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The primary purpose of this study is to determine if single doses of BMS-986166 are safe and well tolerated in healthy male subjects and female subjects of non-childbearing potential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Panel 1 | Experimental | BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified |
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| Dose Panel 2 | Experimental | BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified |
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| Dose Panel 3 | Experimental | BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified |
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| Dose Panel 4 | Experimental | BMS-986166 or Placebo matching BMS-986166 Multiple ascending solid dose formulation as specified |
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| Dose Panel 5a/b/c | Experimental | BMS-986166 Single oral solid dose formulation under fasting/fed/fasting with famotidine conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986166 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All Adverse Events (AEs) | Baseline Day -1 to Day 65 | |
| Incidence of Serious Adverse Events (SAEs) | Baseline Day -1 to Day 65 | |
| Severity of all All Adverse Events (AEs) | Baseline Day -1 to Day 65 | |
| Change from baseline in electrocardiogram(ECG) results | Baseline Day -1 to Day 35 | |
| Change from baseline in body temperature | Baseline Day -1 to Day 35 | |
| Change from baseline in respiratory rate | Baseline Day -1 to Day 35 | |
| Change from baseline in seated blood pressure | Baseline Day -1 to Day 35 | |
| Change from baseline in heart rate | Baseline Day -1 to Day 35 | |
| Change from baseline in clinical laboratory test results | Clinical laboratory testing to include Chemistry analytes and Hematology analytes. | Baseline Day -1 to Day 35 |
| Change from baseline in continuous cardiac monitoring data | Baseline Day -1 to Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean difference in nadir heart rate (HR) and its time-matched HR on Day -1 | Day -1 to Day 4 | |
| Largest decrease in HR from time-matched Day -1 baseline | Day -1 to Day 4 | |
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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 |
|---|---|---|---|---|---|---|
| PPD Development, LLC | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32306792 | Derived | Singhal S, Girgis IG, Xie J, Dutta S, Shevell DE, Throup J. The safety and pharmacokinetics of a novel, selective S1P1R modulator in healthy participants. Expert Opin Investig Drugs. 2020 Apr;29(4):411-422. doi: 10.1080/13543784.2020.1742322. |
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| Placebo matching BMS-986166 |
| Drug |
|
| Change from baseline in physical examination findings | Baseline Day -1 to Day 35 |
| Time to nadir HR from time 0 hour (predose) |
| Day -1 to Day 4 |
| Percent reduction in HR at nadir from time-matched Day -1 HR value | Day -1 to Day 4 |
| Mean change from baseline in HR values by timepoint for BMS-986166-treated versus placebo-treated subjects where the baseline is defined as time-matched Day -1 HR value | Day -1 to Day 7 |
| Mean difference in absolute lymphocyte count (ALC) values and its time-matched ALC on Day -1 in BMS-986166- treated versus placebo-treated subjects | Day -1 to Day 4 |
| Largest decrease in ALC from time-matched Day -1 baseline | Day -1 to Day 4 |
| Time to nadir ALC from time 0 hour (predose) | Day -1 to Day 4 |
| Percent reduction in ALC at nadir from time-matched Day -1 value | Day -1 to Day 4 |
| Mean change from baseline in ALC values by timepoint for BMS-986166-treated versus placebo-treated subjects where the baseline is defined as time-matched Day -1 ALC value | Day -1 to Day 7 |
| ID | Term |
|---|---|
| C000706608 | BMS-986166 |
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