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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986368

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain the NCT# and Site#
• Study Contact Backup: Name: BMS Study Connect www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clincal.Trials@bms.com

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92780
      • Local Institution - 0001
      • Contact: Site 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1A	Drug: BMS-986368; Specified dose on specified days
Experimental: Cohort 1B	Drug: BMS-986368; Specified dose on specified days
Experimental: Cohort 1C	Drug: BMS-986368; Specified dose on specified days
Experimental: Cohort 2A	Drug: BMS-986368; Specified dose on specified days
Experimental: Cohort 2B	Drug: BMS-986368; Specified dose on specified days
Experimental: Cohort 2C	Drug: BMS-986368; Specified dose on specified days
Experimental: Cohort 2D	Drug: BMS-986368; Specified dose on specified days
Experimental: Cohort 3A	Drug: BMS-986368; Specified dose on specified days
Experimental: Cohort 3B	Drug: BMS-986368; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with electrocardiogram (ECG) abnormalities	Up to 21 days
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 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 Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to 16 days
Area under the plasma concentration-time curve (AUC)	Up to 16 days
Time of maximum observed plasma concentration (Tmax)	Up to 16 days
Absolute levels of fatty acid amide hydrolase (FAAH) enzymatic activities in peripheral blood mononuclear cells (PBMCs)	Up to 21 days
Absolute levels of monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)	Up to 21 days
Percent change from baseline for fatty acid amide hydrolase (FAAH) 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
Whole blood concentrations of 2-arachidonoylglycerol (2-AG)	Up to 21 days
Percent change from baseline of 2-arachidonoylglycerol (2-AG)	Up to 21 days

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Estimated): May 14, 2024
• Primary Completion (Estimated): October 8, 2024
• Study Completion (Estimated): October 8, 2024

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Healthy Volunteers; Healthy Participants; Pharmacodynamics; Multiple Ascending Dose; Japanese Volunteers; CC-97489; Elderly Participants; BMS-986368; Elderly Volunteers; Japanese Participants
• Other Study ID Numbers: IM045-1009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No