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

NCT06411730 | Completed Phase 1 FDA Drug

• 1 other identifier: IM045-1009
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Pharmacokinetics; Pharmacodynamics; BMS-986368; CC-97489; Healthy Volunteers; Elderly Volunteers; Japanese Volunteers; Multiple Ascending Dose; Healthy Participants; Elderly Participants; Japanese Participants

Outcome Measures

Primary Outcomes (7)

• 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 electrocardiogram (ECG) 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 Outcomes (9)

• Area under the plasma concentration-time curve (AUC)

  Up to 16 days

• Maximum observed plasma concentration (Cmax)

  Up to 16 days

• Time of maximum observed plasma concentration (Tmax)

  Up to 16 days

• Absolute levels of monoacylglycerol lipase (MGLL) 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

Study Arms (9)

Cohort 1A

EXPERIMENTAL

Drug: BMS-986368

Cohort 1B

EXPERIMENTAL

Drug: BMS-986368

Cohort 1C

EXPERIMENTAL

Drug: BMS-986368

Cohort 2A

EXPERIMENTAL

Drug: BMS-986368

Cohort 2B

EXPERIMENTAL

Drug: BMS-986368

Cohort 2C

EXPERIMENTAL

Drug: BMS-986368

Cohort 2D

EXPERIMENTAL

Drug: BMS-986368

Cohort 3A

EXPERIMENTAL

Drug: BMS-986368

Cohort 3B

EXPERIMENTAL

Drug: BMS-986368

Interventions

BMS-986368 DRUG

Specified dose on specified days

Cohort 1A; Cohort 1B; Cohort 1C; Cohort 2A; Cohort 2B; Cohort 2C; Cohort 2D; Cohort 3A; Cohort 3B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants must not have a personal or first-degree family (individual's parents, siblings, and children) history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, panic disorder, generalized anxiety disorder, and obsessive-compulsive 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).

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Local Institution - 0001

Anaheim, California, 92780, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 13, 2024
• Study Start: May 31, 2024
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

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

Locations

US (1)