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NCT06692322 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy and Liver Diseases, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target
1
Study location

NCT06692322 is a Phase 1 study of Healthy and Liver Diseases that has completed, run by Boehringer Ingelheim. The registered enrollment target is 29 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06692322, a Phase 1 study of Healthy and Liver Diseases, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DRUG Zongertinib (BI 1810631)

Study Locations (1)

Texas

  • American Research Corporation at the Texas Liver Institute - San Antonio

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2025-01-15
Est. Completion 2025-06-20
Phase Phase 1

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT06692322

The ClinicalTrials.gov registry entry for NCT06692322 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Zongertinib (BI 1810631) is the first listed.

NCT06692322 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT06692322 about?

NCT06692322 is a clinical study titled "A Study to Test How Zongertinib is Taken up in the Blood of People With and Without Liver Problems". 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 witho...

What is the current status of trial NCT06692322?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2025-01-15. Estimated completion is 2025-06-20.

What conditions does trial NCT06692322 study?

This clinical trial studies the following conditions: Healthy, Liver Diseases.

What interventions are being tested in trial NCT06692322?

The interventions under investigation include: Zongertinib (BI 1810631) (DRUG).

Who is sponsoring clinical trial NCT06692322?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06692322 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.