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
Phase 1
Terminated
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT06144697
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 267
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys] Pegasys - Part C: MAD in Japanese ethnicity [BMS-986465 or placebo] BMS-986465 - Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys] BMS-986465 - Part C: MAD in Japanese ethnicity [BMS-986465 or placebo] Placebo - Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine] BMS-986465 - Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo] BMS-986465 - Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys] Placebo - Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo] Placebo - Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine] Famotidine -
- Primary Outcome Measures
Name Time Method Number of participants with clinical laboratory abnormalities Up to 28 days Incidence of serious adverse events (SAEs) Up to 28 days Number of participants with vital sign abnormalities Up to 28 days Number of participants with electrocardiogram (ECG) abnormalities Up to 28 days Incidence of adverse events (AEs) Up to 28 days Number of participants with physical examination abnormalities Up to 28 days Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Up to 28 days
- Secondary Outcome Measures
Name Time Method Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] Up to Day 27 Ratios of CSF to plasma concentrations Up to 9 days Maximum observed plasma concentration (Cmax) Up to Day 27 Time of maximum observed plasma concentration (Tmax) Up to Day 27 Cerebrospinal fluid (CSF) concentrations Up to Day 27
Trial Locations
- Locations (2)
Local Institution - 0003
🇺🇸Austin, Texas, United States
Local Institution - 0001
🇺🇸Anaheim, California, United States