CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
midazolam +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05258110
NCT05258110Phase 1Completed
CompareCT.gov

The Effect of Multiple Oral Doses of BI 425809 on Metabolism of Midazolam Administered Orally in Healthy Male Subjects (Open-label, Two-period, One-sequence Trial)

Boehringer Ingelheim·interventional·Posted Feb 28, 2022·Updated Mar 30, 2026

In Brief

A Phase 1 clinical trial evaluating midazolam and iclepertin (BI 425809) for Healthy. Completed, enrolled 15 participants across 1 site.

Detailed Summary

In order to assess the potential impact of steady state BI 425809 on CYP3A clinically, the effect of BI 425809 on the midazolam pharmacokinetics will be evaluated. Midazolam is a recommended substrate of CYP3A4.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedFeb 28, 2022
Enrollment StartMar 18, 2022
Primary CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.3 years ago

Interventions

midazolamdrug

midazolam

iclepertin (BI 425809)drug

BI 425809