drugset / Trial / NCT02534636

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

NCT02534636

Phase 1 Completed 140 enrolled Bristol-Myers Squibb
RandomizedCrossoverQuadruple-blind

Summary

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.

Timeline

Start
2015-10
Primary completion
2016-11
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject CRAVACITINIB Small molecule Oral
Background Famotidine Other / unclassified
Background Peginterferon alfa-2a Protein / enzyme biologic

Indications

No indication recorded.