drugset / Trial / NCT03209648

A Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Debio 1450 in Healthy Subjects

NCT03209648

Phase 1 Completed 20 enrolled Debiopharm International SA
NaSingle-groupOpen-labelTreatment

Summary

Debio 1450 is metabolised mainly by CYP3A4, therefore inhibitors of CYP3A4 have the potential to raise Debio 1450 plasma concentrations. Hence, it is important to determine the effect of CYP3A4 inhibition by itraconazole on the Pharmacokinetics of Debio 1450.

Timeline

Start
2017-06-14
Primary completion
2017-08-23
Completion
2017-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Afabicin Small molecule 40 mg Oral
Subject Itraconazole Small molecule 200 mg Oral

Indications

No indication recorded.