CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Zongertinib +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/NCT05833139
NCT05833139Phase 1Completed
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The Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1810631 in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)

Boehringer Ingelheim·interventional·Posted Apr 27, 2023·Updated Sep 22, 2025

In Brief

A Phase 1 clinical trial evaluating Zongertinib and Itraconazole for Healthy. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The main objective of this trial is to investigate the effect of multiple doses of the strong CYP3A inhibitor and recommended P-glycoprotein (P-gp) inhibitor itraconazole on the pharmacokinetics of a single dose of zongertinib in plasma following oral administration.

Study Details

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

Timeline

Phase 1CompletedFinished
202420252026
First PostedApr 27, 2023
Enrollment StartApr 14, 2023
Primary CompletionJun 12, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.2 years ago

Interventions

Zongertinibdrug

Zongertinib

Itraconazoledrug

Itraconazole