A Study 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
- Registration Number
- NCT06411730
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1A BMS-986368 - Cohort 2C BMS-986368 - Cohort 3A BMS-986368 - Cohort 1B BMS-986368 - Cohort 1C BMS-986368 - Cohort 2A BMS-986368 - Cohort 2B BMS-986368 - Cohort 3B BMS-986368 - Cohort 2D BMS-986368 -
- Primary Outcome Measures
Name Time Method Number of participants with electrocardiogram (ECG) abnormalities Up to 21 days Number of participants with vital sign (VS) abnormalities Up to 21 days Number of participants with adverse events (AEs) Up to 44 days Number of participants with physical examination abnormalities Up to 21 days Number of participants with clinical laboratory asssement abnormalities Up to 21 days Number of participants with serious adverse events (SAEs) Up to 44 days Number of participants with treatment-emergent suicidal ideation and behavior through assessment of Columbia Suicide Severity Rating Scale (C-SSRS) Up to 21 days
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the molecular target of BMS-986368 and its mechanism of action in healthy volunteers?
How does BMS-986368's pharmacokinetics compare to other oral kinase inhibitors in healthy individuals?
What biomarkers correlate with BMS-986368's pharmacokinetic variability in NCT06411730's Japanese and elderly cohorts?
What adverse events are reported in Phase 1 trials of BMS-986368 and their management in healthy volunteers?
What other Celgene compounds are being evaluated for similar pharmacodynamic profiles in early-phase clinical trials?
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Anaheim, California, United States
Local Institution - 0001🇺🇸Anaheim, California, United States