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

NCT07700329 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IM045-1027
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

BMS-986368; CC-97489; Healthy volunteers; Healthy Chinese participants; Pharmacokinetics; Safety; Tolerability; FAAH inhibitor; MAGL inhibitor; Phase 1

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

Study Arms (2)

Cohort 1

EXPERIMENTAL

Drug: BMS-986368; Other: BMS-986368-matching Placebo

Cohort 2

EXPERIMENTAL

Drug: BMS-986368; Other: BMS-986368-matching Placebo

Interventions

BMS-986368 DRUG

Specified dose on specified days

Cohort 1; Cohort 2

BMS-986368-matching Placebo OTHER

Specified dose of specified days

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): January 5, 2027
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): February 23, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description