Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and well tolerated in healthy patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Panel 1 | Experimental | BMS-986166 or Placebo matching BMS-986166 |
|
| Dose Panel 2 | Experimental | BMS-986166 or Placebo matching BMS-986166 |
|
| Dose Panel 3 | Experimental | BMS-986166 or Placebo matching BMS-986166 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986166 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All Adverse Events (AEs) | measured by number of patients | 77 days |
| Incidence of Serious Adverse Events (SAEs) | measured by number of patients | 77 days |
| Severity of all Adverse Events (AEs) | measured by investigator | 77 days |
| Change from baseline in physical examination findings | measured by investigator | 77 days |
| Change from baseline in electrocardiogram (ECG) results | measured by ECG | 77 days |
| Change from baseline in continuous cardiac monitoring data | measured with external monitoring device | 15 days |
| Change from baseline in clinical laboratory test results | measured by serum chemistry, hematology, serology and urinalysis results | 77 days |
| Change from baseline in body temperature | measured in degrees Celsius or Fahrenheit | 77 days |
| Change from baseline in respiratory rate |
| Measure | Description | Time Frame |
|---|---|---|
| Mean heart rate (HR) | Calculated from nadir HR to time-matched HR on Day -1 | 15 days |
| Largest decrease in HR from time-matched Day -1 baseline | measured by investigator |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000706608 | BMS-986166 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo matching BMS-986166 | Other | Specified dose on specified days |
|
measured by investigator |
| 77 days |
| Change from baseline in seated blood pressure | measured by investigator | 77 days |
| Change from baseline in heart rate | measured by investigator | 77 days |
| 15 days |
| Time to nadir HR from time 0 hour (predose) | measured by investigator | 15 days |
| Time to largest decrease HR from time 0 hour (predose) | measured by investigator | 15 days |
| Mean change from baseline in HR values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 HR value | measured by investigator | 15 days |
| Largest percent decrease in absolute lymphocyte count (ALC) from time-matched Day -1 baseline | measured by ALC | 35 days |
| Time to largest percent reduction ALC from time 0 hour (predose) | measured by ALC | 35 days |
| Mean percent change from baseline in ALC values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 ALC value | measured by ALC | 77 days |
| Maximum observed blood concentration (Cmax) | measured by blood concentration versus time data | 77 days |
| Time of maximum observed blood concentration (Tmax) | measured by blood concentration versus time data | 77 days |
| Terminal half-life (T-HALF) | measured by blood concentration versus time data | 77 days |
| Area under the blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | measured by blood concentration versus time data | 77 days |
| Area under the blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | measured by blood concentration versus time data | 77 days |
| Apparent total clearance (CLT/F) | measured by blood concentration versus time data | 77 days |
| Apparent steady state volume (Vz/F) | measured by blood concentration versus time data | 77 days |
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter | 77 days |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] | Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter | 77 days |
| Maximum observed concentration (Cmax) | Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter | 77 days |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |