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

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy Participants
• Intervention / Treatment: Other: Placebo; Drug: Famotidine; Drug: BMS-986465; Drug: Pegasys

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Local Institution - 0001
  • Texas
    • Austin, Texas, United States, 78744
      • Local Institution - 0003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with vital sign abnormalities	Up to 28 days
Number of participants with electrocardiogram (ECG) abnormalities	Up to 28 days
Number of participants with physical examination abnormalities	Up to 28 days
Incidence of adverse events (AEs)	Up to 28 days
Incidence of serious adverse events (SAEs)	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Actual): October 16, 2024
• Study Completion (Actual): October 16, 2024

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Food Effects; Tolerability; Healthy Participants; Pharmacodynamics; SAD; MAD; First-in-human; Healthy Japanese Participants; Formulation; BMS-986465
• Additional Relevant MeSH Terms: Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antiviral Agents; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Anti-Ulcer Agents; Histamine H2 Antagonists; Peginterferon alfa-2a; Famotidine
• Other Study ID Numbers: CN009-1024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No