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

Launched by BRISTOL-MYERS SQUIBB · Nov 21, 2019

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy Participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
• • Body mass index (BMI) of 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusive, and body weight ≥ 50 kg, at screening
• • Women and men must agree to follow methods of contraception.
• Exclusion Criteria:
• • Any significant acute or chronic medical illness
• • History of recent infection
• • History of allergy to BMS-986322 or other compounds
• • Other protocol-defined inclusion/exclusion criteria could apply.