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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: BMS-986322; Other: BMS-986322 Placebo; Drug: famotidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04175925

IM032-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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171 participants in 3 patient groups

Part A: BMS-986322

Experimental group

Treatment:

Other: BMS-986322 Placebo

Drug: BMS-986322

Part B: BMS-986322 Placebo

Experimental group

Treatment:

Other: BMS-986322 Placebo

Drug: BMS-986322

Part C: BMS-986322 with famotidine

Experimental group

Treatment:

Drug: famotidine

Drug: BMS-986322