drugset / Trial / NCT01937260

Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects

NCT01937260

Phase 1 Completed 31 enrolled Bausch Health Americas, Inc.
RandomizedParallel-groupOpen-labelOther

Summary

This is a phase 1, multi-center, open-label, drug-drug interaction (DDI) and PK study in subjects with moderate to severe plaque psoriasis. It is designed to evaluate the effect of brodalumab on midazolam PK in addition to assessing single dose PK of brodalumab in subjects with moderate to severe plaque psoriasis.

Timeline

Start
2013-09
Primary completion
2014-07
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Brodalumab Monoclonal antibody 140 mg Subcutaneous
Subject Brodalumab Monoclonal antibody 210 mg Subcutaneous

Indications