drugset / Trial / NCT02753218

A Phase I Study With LEO 32731 and Midazolam in Healthy Male Subjects

NCT02753218 ↗

Phase 1 Terminated 12 enrolled LEO Pharma
NaSingle-groupOpen-labelOther

Summary

The purpose of this study is to investigate the effects of multiple oral doses of LEO 32731 on the pharmacokinetics of a single oral dose of the cytochrome P450 3A substrate midazolam in healthy male subjects.

Timeline

Start
2016-04
Primary completion
2016-05
Completion
2016-05

Outcome

Outcome not reported

Stopped: “Due to tolerability issues related to the dose titration, unexpected withdrawals were observed and it was unlikely for the trial to meet its objectives”

Drugs

EvaluationDrugModalityDoseRoute
Subject LEO 32731 Unknown — Oral
Subject Midazolam Small molecule — Oral

Indications