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Trials / Completed

CompletedNCT05258110

A Study in Healthy Men to Test Whether BI 425809 Influences the Amount of Midazolam in the Blood

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)

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Boehringer Ingelheim · Industry
Sex
Male
Age
18 Years – 55 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGmidazolammidazolam
DRUGiclepertin (BI 425809)BI 425809

Timeline

Start date
2022-03-18
Primary completion
2022-05-31
Completion
2022-05-31
First posted
2022-02-28
Last updated
2026-03-30
Results posted
2026-03-30

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT05258110. Inclusion in this directory is not an endorsement.

A Study in Healthy Men to Test Whether BI 425809 Influences the Amount of Midazolam in the Blood (NCT05258110) · Clinical Trials Directory