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A Study to Test How Zongertinib is Taken up in the Blood of People With and Without Liver Problems | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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)

NCT06692322•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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects of non-childbearing potential. Female subjects must be of non-childbearing potential either be a) postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle stimulating hormone (FSH) above 25 U/L and estradiol below 30 ng/L is confirmatory) or b) have proof of acceptable surgical sterilization. Subjects must use condom from time point of administration of trial medication until 30 days after drug administration.
•Age of 18 to 80 years (inclusive)
•Body mass index (BMI) of 18.0 to 42 kg/m\^2 (inclusive)
•Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
•Male subjects with Women of child-bearing potential (WOCBP) partner must be willing to use highly effective methods of contraception (condom in combination with other methods or sexual abstinence) from time point of administration of trial medication until 30 days thereafter. These include:
•* Subject uses condoms
•* Subject is sexually abstinent
•* Subject is vasectomized (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate) and uses condom
•Additionally female partners of male subjects must be willing to use any of the following criteria for a highly effective contraception from at least 30 days before the first administration of the male partner until 30 days thereafter:
•Use of intrauterine device or intrauterine hormone-releasing system by female partner plus use of condom
+6 more criteria

Exclusion Criteria

•Any finding in the medical examination (including BP, PR or ECG) assessed as clinically relevant by the investigator (apart from any non-severe hepatic impairment and associated underlying diseases)
•Severe hepatic impairment (classified as Child-Pugh C or score 10-15)
•Any laboratory value outside the reference range that the investigator considers to be of clinical relevance (apart from values due to underlying disease)
•Any evidence of a concomitant disease assessed as clinically relevant by the investigator (apart from underlying disease)
•Severe gastrointestinal, renal (Estimated glomerular filtration rate (eGFR) Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) \<40 ml/min/1.73 m2 for the hepatic impaired patients and eGFR CKD-EPI \<90 ml/min/1.73 m2 for matched controls), respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the Investigator.
•Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
•Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Locations (1)

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, United States

Key Dates

Start Date

January 15, 2025

Primary Completion Date

June 20, 2025

Completion Date

June 20, 2025

Last Updated

August 15, 2025

Enrollment

ACTUAL participants

Conditions

Liver DiseasesHealthy

Interventions

Zongertinib (BI 1810631)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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