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

NCT06144697 | Terminated Phase 1 FDA Drug

• 1 other identifier: CN009-1024
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Participants

Keywords

Pharmacokinetics; Pharmacodynamics; Healthy Participants; Healthy Japanese Participants; BMS-986465; SAD; MAD; Safety; Tolerability; Food Effects; Formulation; First-in-human

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• 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

Study Arms (4)

Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo]

EXPERIMENTAL

Drug: BMS-986465; Other: Placebo

Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]

EXPERIMENTAL

Drug: BMS-986465; Other: Placebo; Drug: Pegasys

Part C: MAD in Japanese ethnicity [BMS-986465 or placebo]

EXPERIMENTAL

Drug: BMS-986465; Other: Placebo

Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine]

EXPERIMENTAL

Drug: BMS-986465; Drug: Famotidine

Interventions

BMS-986465 DRUG

Specified dose on specified days

Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo]; Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]; Part C: MAD in Japanese ethnicity [BMS-986465 or placebo]; Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine]

Placebo OTHER

Specified dose on specified days

Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo]; Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]; Part C: MAD in Japanese ethnicity [BMS-986465 or placebo]

Pegasys DRUG

Specified dose on specified days

Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]

Famotidine DRUG

Specified dose on specified days

Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine]

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0001

Anaheim, California, 92801, United States

Location

Local Institution - 0003

Austin, Texas, 78744, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

peginterferon alfa-2a; Famotidine

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 22, 2023
• Study Start: January 29, 2024
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)