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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Boehringer Ingelheim
Study ID
NCT06692322
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Liver Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Nov 18, 2024
Start date
Jan 15, 2025
Status verified
Aug 2025
Primary completion
Jun 20, 2025
Completion
Jun 20, 2025

Study Design

Enrollment
29 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mild hepatic impairment (Child-Pugh A)
  • Experimental: Moderate hepatic impairment (Child-Pugh B)
  • Experimental: Normal hepatic function

Primary Outcome Measure

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity (AUC0-∞) [ Time Frame: up to 8 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
American Research Corporation at the Texas Liver InstituteSan AntonioTexas78215-

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By research site
American Research Corporation at the Texas Liver Institute· San Antonio, TX

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