drugset / Trial / NCT02199431

Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers.

NCT02199431 ↗

Phase 1 Completed 20 enrolled H. Lundbeck A/S
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status as CYP2C19 extensive metabolisers

Timeline

Start
2014-07
Primary completion
2015-02
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule 200 mg Oral
Subject Lu AF11167 Unknown 0.5 mg Oral

Indications

No indication recorded.