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
- 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.
- Short title
- 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
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Reason stopped
- Business objectives have changed
- Completion date
- 2024-10-16
- First posted
- 2023-11-22
- Registry last updated
- 2025-02-06
- Primary completion date
- 2024-10-16
- Start date
- 2024-01-29
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Bristol-Myers Squibb
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06144697
- ClinicalTrials.gov ID
- NCT06144697
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Incidence of adverse events (AEs)
Timeframe: Up to 28 days
Incidence of serious adverse events (SAEs)
Timeframe: Up to 28 days
Number of participants with vital sign abnormalities
Timeframe: Up to 28 days
Number of participants with physical examination abnormalities
Timeframe: Up to 28 days
Number of participants with electrocardiogram (ECG) abnormalities
Timeframe: Up to 28 days
Number of participants with clinical laboratory abnormalities
Timeframe: Up to 28 days
Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Timeframe: Up to 28 days
Maximum observed plasma concentration (Cmax)
Timeframe: Up to Day 27
Time of maximum observed plasma concentration (Tmax)
Timeframe: Up to Day 27
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
Cerebrospinal fluid (CSF) concentrations
Timeframe: Up to Day 27
Ratios of CSF to plasma concentrations
Timeframe: Up to 9 days
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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)
- 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
- Local Institution - 0001Anaheim, United States
- Local Institution - 0003Austin, United States
- Related resource (www.bms.com)
- Related resource (www.bmsclinicaltrials.com)