NCT06144697

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	BMS-986465	Specified dose on specified days
OTHER	Placebo	Specified dose on specified days
DRUG	Pegasys	Specified dose on specified days
DRUG	Famotidine	Specified dose on specified days

Timeline

• Start date: 2024-01-29
• Primary completion: 2024-10-16
• Completion: 2024-10-16
• First posted: 2023-11-22
• Last updated: 2025-02-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study