CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
zongertinibdrug
Likely dose
zongertinib 240 mgfrom 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/NCT06075277
NCT06075277Phase 1Completed
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Relative Bioavailability of BI 1810631 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)

Boehringer Ingelheim·interventional·Posted Oct 10, 2023·Updated Sep 22, 2025

In Brief

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

Detailed Summary

The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1810631 intended commercial formulation (iCF) under fed (Test treatment, T) and fasted (Reference treatment, R) conditions.

Study Details

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

Timeline

Phase 1CompletedFinished
202420252026
First PostedOct 10, 2023
Enrollment StartOct 19, 2023
Primary CompletionJan 2, 2024
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 2.7 years ago

Interventions

zongertinibdrug

Participants received a single oral dose of 240 mg Zongertinib (4 x 60 mg tablets) in two periods: in Period 1 after an overnight fast of at least 10 hours, and in Period 2 following a high fat/high calorie meal.