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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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06144697
Enrollment
267
Registered
2023-11-22
Start date
2024-01-29
Completion date
2024-10-16
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

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

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.

Interventions

DRUGBMS-986465

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days

DRUGPegasys

Specified dose on specified days

DRUGFamotidine

Specified dose on specified days

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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/

Design outcomes

Primary

MeasureTime frame
Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)Up to 28 days
Incidence of serious adverse events (SAEs)Up to 28 days
Number of participants with vital sign abnormalitiesUp to 28 days
Number of participants with physical examination abnormalitiesUp to 28 days
Number of participants with electrocardiogram (ECG) abnormalitiesUp to 28 days
Number of participants with clinical laboratory abnormalitiesUp to 28 days
Incidence of adverse events (AEs)Up to 28 days

Secondary

MeasureTime frame
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) concentrationsUp to Day 27
Ratios of CSF to plasma concentrationsUp to 9 days
Maximum observed plasma concentration (Cmax)Up to Day 27

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026