A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity
Overview
- Phase
- Phase 1
- Intervention
- BMS-986368
- Conditions
- Healthy Participants
- Sponsor
- Celgene
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Number of participants with electrocardiogram (ECG) abnormalities
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and drug levels of orally administered BMS-986368 in healthy participants, healthy elderly participants, and healthy participants of japanese ethnicity.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 2D
Intervention: BMS-986368
Cohort 1A
Intervention: BMS-986368
Cohort 1B
Intervention: BMS-986368
Cohort 1C
Intervention: BMS-986368
Cohort 2A
Intervention: BMS-986368
Cohort 2B
Intervention: BMS-986368
Cohort 2C
Intervention: BMS-986368
Cohort 3A
Intervention: BMS-986368
Cohort 3B
Intervention: BMS-986368
Outcomes
Primary Outcomes
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 21 days
Number of participants with vital sign (VS) abnormalities
Time Frame: Up to 21 days
Number of participants with adverse events (AEs)
Time Frame: Up to 44 days
Number of participants with physical examination abnormalities
Time Frame: Up to 21 days
Number of participants with clinical laboratory asssement abnormalities
Time Frame: Up to 21 days
Number of participants with treatment-emergent suicidal ideation and behavior through assessment of Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to 21 days
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 44 days
Secondary Outcomes
- Maximum observed plasma concentration (Cmax)(Up to 16 days)
- Absolute levels of monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)(Up to 21 days)
- Whole blood concentrations of 2-arachidonoylglycerol (2-AG)(Up to 21 days)
- Area under the plasma concentration-time curve (AUC)(Up to 16 days)
- Time of maximum observed plasma concentration (Tmax)(Up to 16 days)
- Percent change from baseline for monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)(Up to 21 days)
- Percent change from baseline of anandamide (AEA)(Up to 21 days)
- Plasma concentrations of anandamide (AEA)(Up to 21 days)
- Percent change from baseline of 2-arachidonoylglycerol (2-AG)(Up to 21 days)