drugset / Trial / NCT03126578

Open-label, Single Center, Non-randomized, Fixed Sequence Phase 1 Drug-drug Interaction Study With LEO 32731 and Midazolam

NCT03126578 ↗

Phase 1 Completed 32 enrolled LEO Pharma
NaSingle-groupOpen-labelTreatment

Summary

This is a single center, non-randomized, open-label, fixed sequence study to investigate the effect of multiple oral dosing of LEO 32731 (up-titrated), on CYP3A activity in healthy male subjects using midazolam as a probe CYP3A substrate. The study will be conducted in two seamless parts: Part I - Maximal Tolerated Dose (MTD) Part II - Drug-Drug Interaction with midazolam

Timeline

Start
2017-05-31
Primary completion
2017-10-20
Completion
2017-10-20

Drugs

EvaluationDrugModalityDoseRoute
Subject LEO 32731 Unknown 40 mg Oral
Subject Midazolam Small molecule 2.5 mg Oral

Indications

No indication recorded.