NCT05879991

A Study in Healthy Men to Test How Zongertinib (BI 1810631) is Taken up and Processed by the Body

A Phase I, Open-label Trial in Two Parallel Parts to Investigate Mass Balance, Metabolism, and Basic Pharmacokinetics of BI 1810631 (C-14) Administered as Oral Solution (Part A) and to Investigate Absolute Bioavailability of BI 1810631 Administered as Film-coated Tablet Together With an Intravenous Microtracer Dose of BI 1810631 (C-14) (Part B) in Healthy Male Volunteers

• 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

Part A - the primary objective is to assess the mass balance and total recovery of \[14C\]-radioactivity in urine and faeces after oral single dose administration of BI 1810631 (C-14) (test treatment T1) in healthy male subjects. Part A - the secondary objective is to assess concentrations of BI 1810631 and \[14C\]-radioactivity in plasma. Part B - the primary objective is to investigate the absolute bioavailability of BI 1810631 administered as film-coated tablet (test treatment T2, not radio-labelled) compared with BI 1810631 (C-14) (reference treatment R) administered as intravenous microtracer.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	zongertinib (C-14)	Oral solution
DRUG	zongertinib	Film-coated tablet
DRUG	zongertinib (C-14)	Solution for infusion

Timeline

• Start date: 2023-08-10
• Primary completion: 2023-10-19
• Completion: 2023-10-19
• First posted: 2023-05-30
• Last updated: 2025-10-06
• Results posted: 2025-09-22

Locations

1 site across 1 country: Netherlands