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

NCT05879991 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-10-06

Study results available
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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

DRUG

zongertinib (C-14)

Oral solution

DRUG

zongertinib

Film-coated tablet

DRUG

zongertinib (C-14)

Solution for infusion

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-10
Primary Completion
2023-10-19
Completion
2023-10-19

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05879991 on ClinicalTrials.gov