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NCT06692322
PHASE1

A Study to Test How Zongertinib is Taken up in the Blood of People With and Without Liver Problems

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m\^2 can take part. Women can only participate if they cannot get pregnant. This study includes people with mild liver problems, people with moderate liver problems, and people without liver problems as a matching control. The purpose of this study is to find out how mild and moderate liver problems affect how the body handles a medicine called zongertinib. Participants take zongertinib once as tablets. Participants with liver problems are treated in a step-by-step approach with a few days in between for the doctors to review the data and make sure the participants can tolerate the treatment. Participants may continue their regular treatment for their liver problems during the study. Participants are in the study for about 5 weeks. During this time, they visit the study site 4 times. This also includes an overnight stay for 6 nights. During study visits, the doctors regularly check participants' health and take note of any unwanted effects. To assess the study endpoints, the study staff regularly takes blood samples.

Official title: Pharmacokinetics, Safety and Tolerability of Zongertinib Following Oral Administration in Male and Female Participants of Non-childbearing Potential With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) Compared With Matched Male and Female Participants of Non-childbearing Potential With Normal Hepatic Function (an Open-label, Non-randomised, Single-dose, Parallel, Individual-matched Design Trial)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2025-01-15

Completion Date

2025-06-20

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

DRUG

Zongertinib

Participants received a single oral dose of 120 milligrams (mg) of zongertinib with 240 milliliters (mL) of water, following an overnight fast of at least 10 hrs

Locations (1)

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, United States