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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06411730
• Other study ID #: IM045-1009
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Healthy Participants

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

External Links

•   BMS Clinical Trial Information