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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986465
* Other: Placebo
* Drug: Pegasys
* Drug: Famotidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo]<br> | Drug: BMS-986465<br>* Specified dose on specified days<br>Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]<br> | Drug: BMS-986465<br>* Specified dose on specified days<br>Other: Placebo<br>* Specified dose on specified days<br>Drug: Pegasys<br>* Specified dose on specified days<br>|
| Experimental: Part C: MAD in Japanese ethnicity [BMS-986465 or placebo]<br> | Drug: BMS-986465<br>* Specified dose on specified days<br>Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine]<br> | Drug: BMS-986465<br>* Specified dose on specified days<br>Drug: Famotidine<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | 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 physical examination abnormalities |  | Up to 28 days | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 28 days | 
| Number of participants with clinical laboratory 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to Day 27 | 
| Time of maximum observed plasma concentration (Tmax) |  | 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 | 
| Ratios of CSF to plasma concentrations |  | Up to 9 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Pharmacodynamics, Healthy Participants, Healthy Japanese Participants, BMS-986465, SAD, MAD, Safety, Tolerability, Food Effects, Formulation, First-in-human