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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06411730
Other study ID # IM045-1009
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 31, 2024
Est. completion date October 8, 2024

Study information

Verified date June 2024
Source Celgene
Contact BMS Study Connect www.BMSStudyConnect.com
Phone 855-907-3286
Email Clincal.Trials@bms.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date October 8, 2024
Est. primary completion date October 8, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-986368
Specified dose on specified days

Locations

Country Name City State
United States Anaheim Clinical Trials (ACT) Anaheim California

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events (AEs) Up to 44 days
Primary Number of participants with serious adverse events (SAEs) Up to 44 days
Primary Number of participants with vital sign (VS) abnormalities Up to 21 days
Primary Number of participants with physical examination abnormalities Up to 21 days
Primary Number of participants with electrocardiogram (ECG) abnormalities Up to 21 days
Primary Number of participants with clinical laboratory asssement abnormalities Up to 21 days
Primary 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 Area under the plasma concentration-time curve (AUC) Up to 16 days
Secondary Maximum observed plasma concentration (Cmax) Up to 16 days
Secondary Time of maximum observed plasma concentration (Tmax) Up to 16 days
Secondary Absolute levels of fatty acid amide hydrolase (FAAH) enzymatic activities in peripheral blood mononuclear cells (PBMCs) Up to 21 days
Secondary Absolute levels of monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs) Up to 21 days
Secondary Percent change from baseline for fatty acid amide hydrolase (FAAH) enzymatic activities in peripheral blood mononuclear cells (PBMCs) Up to 21 days
Secondary Percent change from baseline for monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs) Up to 21 days
Secondary Plasma concentrations of anandamide (AEA) Up to 21 days
Secondary Percent change from baseline of anandamide (AEA) Up to 21 days
Secondary Whole blood concentrations of 2-arachidonoylglycerol (2-AG) Up to 21 days
Secondary Percent change from baseline of 2-arachidonoylglycerol (2-AG) Up to 21 days
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