Clinical trial NCT06144697: A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Prodrug BMS-986465 and Its Active Derivative, BMS-986464, in Healthy Participants Including Healthy Participants of Japanese Ethnicity and an Open-label Assessment of Food, Formulation, and pH Effects on the Relative Bioavailability of BMS-986465 and BMS-986464
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Pharmacokinetics
Pharmacodynamics
Healthy Participants
Healthy Japanese Participants
BMS-986465
SAD
MAD
Safety
Tolerability
Food Effects
Formulation
First-in-human
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-11-22
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female (i e, women not of childbearing potential) participants
* Body Mass Index (BMI) of 18 to 32 kg\^m2 and total body weight ≥ 50 kg
* Parts A, B, and D: Participants without restriction on ethnicity
* Part C: Participants of Japanese ethnicity (both biological parents are ethnically Japanese)

Exclusion Criteria:

* Clinically significant medical, psychiatric and/or sound social reason, as determined by the investigator
* Any major surgery within 3 months of study intervention administration
* Participation in another clinical trial concurrent with this study

Note: Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 28 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 28 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 28 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 28 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 28 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 28 days
measure: Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to 28 days
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 27
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to Day 27
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
timeFrame: Up to Day 27
measure: Cerebrospinal fluid (CSF) concentrations
timeFrame: Up to Day 27
measure: Ratios of CSF to plasma concentrations
timeFrame: Up to 9 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Local Institution - 0001
state: California
city: Austin
country: United States
facility: Local Institution - 0003
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: