A Study to Evaluate the Blood Levels, Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants

A Phase 1, Double-Blinded, Randomized, Placebo-Controlled, Two Parallel Cohort Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants

The purpose of the study is to evaluate the drug levels, safety and tolerability of BMS-986368 in healthy Chinese participants

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: BMS-986368; Other: BMS-986368-matching Placebo

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participants must be healthy male or non-pregnant and non-nursing female (as assigned at birth).
• Participants must be of Chinese ethnicity (both biological parents should be ethnically Chinese).
• Participants must have BMI of 18.0 kg/m2 to 28.0 kg/m2, inclusive and body weight of ≥ 50 kg.

Exclusion Criteria:

• Participants must not have personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, major depressive disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Participants with a history of anxiety may be enrolled at the discretion of the investigator.
• Participants must not have an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1	Drug: BMS-986368; Specified dose on specified days; Other: BMS-986368-matching Placebo; Specified dose of specified days
Experimental: Cohort 2	Drug: BMS-986368; Specified dose on specified days; Other: BMS-986368-matching Placebo; Specified dose of specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration (Cmax)	Up to approximately Day 17
Time of maximum observed concentration (Tmax)	Up to approximately Day 17
Area under the concentration-time curve (AUC)	Up to approximately Day 17

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events (AEs)	Up to approximately Day 44
Number of participants with serious adverse events (SAEs)	Up to approximately Day 44
Number of participants with clinically significant vital sign measurements	Up to approximately Day 17
Number of participants with clinically significant 12-lead electrocardiogram (ECG) examinations	Up to approximately Day 17
Number of participants with clinically significant laboratory assessments	Up to approximately Day 17
Number of participants with treatment emergent suicidal ideation and behavious assessed by Columbia Suicide Severity Rating Scale (C-SSRS)	Up to approximately Day 17
Number of participants with changes with anxiety as assessed by Beck Anxiety Inventory (BAI)	Up to approximately Day 17

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): January 5, 2027
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): February 23, 2027

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Healthy volunteers; Safety; Pharmacokinetics; Phase 1; Tolerability; CC-97489; BMS-986368; FAAH inhibitor; Healthy Chinese participants; MAGL inhibitor
• Other Study ID Numbers: IM045-1027

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.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
• product manufactured in and exported from the U.S.: Yes