Clinical trial NCT06411730: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Pharmacokinetics
Pharmacodynamics
BMS-986368
CC-97489
Healthy Volunteers
Elderly Volunteers
Japanese Volunteers
Multiple Ascending Dose
Healthy Participants
Elderly Participants
Japanese Participants
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2024-05-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/Exclusion criteria apply.

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 44 days
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 44 days
measure: Number of participants with vital sign (VS) abnormalities
timeFrame: Up to 21 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 21 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 21 days
measure: Number of participants with clinical laboratory asssement abnormalities
timeFrame: Up to 21 days
measure: Number of participants with treatment-emergent suicidal ideation and behavior through assessment of Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to 21 days
Secondary outcomes:
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Up to 16 days
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 16 days
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 16 days
measure: Absolute levels of monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)
timeFrame: Up to 21 days
measure: Percent change from baseline for monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)
timeFrame: Up to 21 days
measure: Plasma concentrations of anandamide (AEA)
timeFrame: Up to 21 days
measure: Percent change from baseline of anandamide (AEA)
timeFrame: Up to 21 days
measure: Whole blood concentrations of 2-arachidonoylglycerol (2-AG)
timeFrame: Up to 21 days
measure: Percent change from baseline of 2-arachidonoylglycerol (2-AG)
timeFrame: Up to 21 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Local Institution - 0001
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: