NCT06075277

A Study in Healthy Men to Test How Zongertinib is Taken up in the Body When Taken With or Without Food

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	zongertinib	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.

Timeline

• Start date: 2023-10-19
• Primary completion: 2024-01-02
• Completion: 2024-01-02
• First posted: 2023-10-10
• Last updated: 2025-09-22
• Results posted: 2025-09-22

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study