Healthy Volunteers
Conditions
Keywords
BMS-986368, CC-97489, Healthy volunteers, Healthy Chinese participants, Pharmacokinetics, Safety, Tolerability, FAAH inhibitor, MAGL inhibitor, Phase 1
Brief summary
The purpose of the study is to evaluate the drug levels, safety and tolerability of BMS-986368 in healthy Chinese participants
Interventions
DRUGBMS-986368
Specified dose on specified days
OTHERBMS-986368-matching Placebo
Specified dose of specified days
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be healthy male or non-pregnant and non-nursing female (as assigned at birth). * Participants must be of Chinese ethnicity (both biological parents should be ethnically Chinese). * Participants must have BMI of 18.0 kg/m2 to 28.0 kg/m2, inclusive and body weight of ≥ 50 kg.
Exclusion criteria
* Participants must not have personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, major depressive disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Participants with a history of anxiety may be enrolled at the discretion of the investigator. * Participants must not have an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) | Up to approximately Day 17 |
| Time of maximum observed concentration (Tmax) | Up to approximately Day 17 |
| Area under the concentration-time curve (AUC) | Up to approximately Day 17 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to approximately Day 44 |
| Number of participants with serious adverse events (SAEs) | Up to approximately Day 44 |
| Number of participants with clinically significant vital sign measurements | Up to approximately Day 17 |
| Number of participants with clinically significant 12-lead electrocardiogram (ECG) examinations | Up to approximately Day 17 |
| Number of participants with clinically significant laboratory assessments | Up to approximately Day 17 |
| Number of participants with treatment emergent suicidal ideation and behavious assessed by Columbia Suicide Severity Rating Scale (C-SSRS) | Up to approximately Day 17 |
| Number of participants with changes with anxiety as assessed by Beck Anxiety Inventory (BAI) | Up to approximately Day 17 |
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed