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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy Participants
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 267
- Locations
- 2
- Primary Endpoint
- Number of participants with clinical laboratory abnormalities
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
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
Arms & Interventions
Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo]
Intervention: Placebo
Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo]
Intervention: BMS-986465
Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]
Intervention: BMS-986465
Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]
Intervention: Placebo
Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]
Intervention: Pegasys
Part C: MAD in Japanese ethnicity [BMS-986465 or placebo]
Intervention: BMS-986465
Part C: MAD in Japanese ethnicity [BMS-986465 or placebo]
Intervention: Placebo
Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine]
Intervention: BMS-986465
Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine]
Intervention: Famotidine
Outcomes
Primary Outcomes
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 28 days
Incidence of serious adverse events (SAEs)
Time Frame: Up to 28 days
Number of participants with vital sign abnormalities
Time Frame: Up to 28 days
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 28 days
Incidence of adverse events (AEs)
Time Frame: Up to 28 days
Number of participants with physical examination abnormalities
Time Frame: Up to 28 days
Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to 28 days
Secondary Outcomes
- Time of maximum observed plasma concentration (Tmax)(Up to Day 27)
- Ratios of CSF to plasma concentrations(Up to 9 days)
- Maximum observed plasma concentration (Cmax)(Up to Day 27)
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)](Up to Day 27)
- Cerebrospinal fluid (CSF) concentrations(Up to Day 27)