NCT04175925

A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants

A Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986322 in Healthy Participants Including an Open-label Assessment of Food and pH Effects on Relative Bioavailability of BMS-986322

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A Study assessing the drug levels and drug effects of variable doses of BMS-986322 in Healthy Participants compared to a placebo. The study also assesses how BMS-986322 affects the body with food and its acidity levels.

Detailed description

Recruitment temporarily on hold due to COVID-19. This is a randomized, double-blind, placebo-controlled study which will investigate the safety, tolerability, and PK of single and multiple oral doses of BMS-986322 in healthy subjects. The trial consists of three parts: Part A - a single ascending dose (SAD) safety and pharmacokinetic (PK) evaluation; Part B -a multiple ascending dose (MAD) safety, PK, and pharmacodynamic (PD) evaluation; and Part C - effect of food and pH on PK and safety.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	BMS-986322	Specified Dose on Specified Days
OTHER	BMS-986322 Placebo	Specified Dose on Specified Days
DRUG	famotidine	Specified Dose on Specified Days

Timeline

• Start date: 2019-11-15
• Primary completion: 2021-07-13
• Completion: 2021-07-13
• First posted: 2019-11-25
• Last updated: 2022-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study