Healthy Participants
Conditions
Keywords
Pharmacokinetics, Pharmacodynamics, BMS-986368, CC-97489, Healthy Volunteers, Elderly Volunteers, Japanese Volunteers, Multiple Ascending Dose, Healthy Participants, Elderly Participants, Japanese Participants
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.
Interventions
DRUGBMS-986368
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be healthy male or non-pregnant and non-nursing female individuals. * For Part 2 only, participants must be of Japanese ethnicity (both biological parents are ethnically Japanese). * Participants must have a body mass index (BMI) of 18.0 kg/m2 to 33.0 kg/m2, inclusive. * Participants must have normal renal function at screening.
Exclusion criteria
* Participants must not have a personal or first-degree family (individual's parents, siblings, and children) history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, panic disorder, generalized anxiety disorder, and obsessive-compulsive disorder. * Participants must not have any significant acute or chronic neurological illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etc) as determined by the investigator. * Participants must not have a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases including but not limited to peptic ulcer disease, or significant GI bleeding, pancreatitis, hypokalemia. * Participants must not have had a SARS-CoV-2 infection within 2 weeks prior to screening. * Participants must not have a history of any significant drug allergy or hypersensitivity (such as anaphylaxis or hepatotoxicity). * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to 44 days |
| Number of participants with serious adverse events (SAEs) | Up to 44 days |
| Number of participants with vital sign (VS) abnormalities | Up to 21 days |
| Number of participants with physical examination abnormalities | Up to 21 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 21 days |
| Number of participants with clinical laboratory asssement abnormalities | Up to 21 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
| Measure | Time frame |
|---|---|
| Whole blood concentrations of 2-arachidonoylglycerol (2-AG) | Up to 21 days |
| Area under the plasma concentration-time curve (AUC) | Up to 16 days |
| Percent change from baseline of 2-arachidonoylglycerol (2-AG) | Up to 21 days |
| Maximum observed plasma concentration (Cmax) | Up to 16 days |
| Time of maximum observed plasma concentration (Tmax) | Up to 16 days |
| Absolute levels of monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs) | Up to 21 days |
| Percent change from baseline for monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs) | Up to 21 days |
| Plasma concentrations of anandamide (AEA) | Up to 21 days |
| Percent change from baseline of anandamide (AEA) | Up to 21 days |
Countries
United States
Outcome results
None listed