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Not yet recruiting NCT07700329

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

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-986368, BMS-986368-matching Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug BMS-986368
    Specified dose on specified days
  • Other BMS-986368-matching Placebo
    Specified dose of specified days

Primary outcome measures

  • Maximum observed concentration (Cmax) [Time frame: Up to approximately Day 17]
  • Time of maximum observed concentration (Tmax) [Time frame: Up to approximately Day 17]
  • Area under the concentration-time curve (AUC) [Time frame: Up to approximately Day 17]
Secondary outcome measures (7)
  • Number of participants with adverse events (AEs) [Time frame: Up to approximately Day 44]
  • Number of participants with serious adverse events (SAEs) [Time frame: Up to approximately Day 44]
  • Number of participants with clinically significant vital sign measurements [Time frame: Up to approximately Day 17]
  • Number of participants with clinically significant 12-lead electrocardiogram (ECG) examinations [Time frame: Up to approximately Day 17]
  • Number of participants with clinically significant laboratory assessments [Time frame: Up to approximately Day 17]
  • Number of participants with treatment emergent suicidal ideation and behavious assessed by Columbia Suicide Severity Rating Scale (C-SSRS) [Time frame: Up to approximately Day 17]
  • Number of participants with changes with anxiety as assessed by Beck Anxiety Inventory (BAI) [Time frame: Up to approximately Day 17]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07700329 · IM045-1027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗