NCT05684289

A Study Investigating the Safety, Tolerability, Drug Levels and Drug Effect of BMS-986278 in Healthy Adult Participants (Part 1) and Japanese Participants (Part 2)

A Phase 1, 2-Part, Randomized, Double-Blind, Placebo-controlled, Multiple Dose Study to Test the Potential Interaction of a PDE5 Inhibitor With BMS-986278 and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986278 in Healthy Adult Participants (Part 1) and in Japanese Participants (Part 2)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effect of BMS-986278 in healthy adult participants and Japanese participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	BMS-986278	Specified dose on specified days
DRUG	Sildenafil	Specified dose on specified days
DRUG	Placebo	Specified dose on specified days

Timeline

• Start date: 2023-01-03
• Primary completion: 2023-05-02
• Completion: 2023-05-02
• First posted: 2023-01-13
• Last updated: 2023-08-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study