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

NCT06692322 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1479-0020U1111-1307-9446
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Diseases; Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity (AUC0-∞)

  up to 8 days

• Maximum measured concentration of the analyte in plasma (Cmax)

  up to 8 days

Secondary Outcomes (1)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

  up to 8 days

Study Arms (3)

Mild hepatic impairment (Child-Pugh A)

EXPERIMENTAL

Drug: Zongertinib (BI 1810631)

Moderate hepatic impairment (Child-Pugh B)

EXPERIMENTAL

Drug: Zongertinib (BI 1810631)

Normal hepatic function

EXPERIMENTAL

Drug: Zongertinib (BI 1810631)

Interventions

Zongertinib (BI 1810631) DRUG

Film-coated tablet

Also known as: BI 1810631, Hernexeos®

Mild hepatic impairment (Child-Pugh A); Moderate hepatic impairment (Child-Pugh B); Normal hepatic function

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Use of progestogen-only hormonal contraception by female partner that inhibits ovulation (injectables or implants) plus use of condom
• Use of combined (estrogen and progestogen containing) hormonal contraception by female partner that prevents ovulation (oral, intravaginal, or transdermal) plus use of condom
• Surgically sterilised (including hysterectomy or bilateral tubular occlusion) plus use of condom
• Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of FSH above 25 U/L and estradiol below 30 ng/L is confirmatory) plus use of condom
• For group 1 and 2 only: Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 18, 2024
• Study Start: January 15, 2025
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)