Safety Study of BMS-986165 in Healthy Subjects and to Treat Psoriasis

Bristol-Myers Squibb140 enrolled

Overview

The purpose of this study is to establish if BMS-986165 is safe and effective at treating autoimmune diseases. BMS-986165 which has shown some promise in preclinical studies for inhibiting autoimmune conditions. This study will be the first time this drug is given to humans, and will be conducted entirely in healthy subjects. It will be run in 4 Parts. Part A will investigate single oral doses of drug. Part B will investigate giving the drug daily for 14 days. Part C will investigate daily doses for 14 days in healthy volunteers with Japanese decent. Part D will investigate whether food, stomach acidity or giving the drug in a capsule makes a difference to the safety and potential use of this drug.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

140

Conditions

Healthy Subjects

Interventions

BMS-986165

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy Male and Female participants * 18 to 50 years of age (Parts A-D) Exclusion Criteria: * Participants that had recent infections * Participants with low blood pressure or increased heart rate * Participants with any chronic health related problems * Participants with active cancer within the last 5 years * Participants with any other major medical illness

Outcomes

Primary Outcomes

Safety of a single oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations

Adverse Event (AE), Serious adverse event (SAE)