Liver DiseasesPhase 1NCT06692322

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

A Phase 1 study testing Zongertinib in people with Liver Diseases and Healthy, run by Boehringer Ingelheim at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Liver Diseases, Healthy
What is being tested?: Zongertinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2025to 20 Jun 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 17Show fewer

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)
For group 1 and 2 only: Absence of clinically significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12- lead Electrocardiogram (ECG), and clinical laboratory tests at both screening and admission to trial site, with the exception of findings that in the opinion of the investigator are consistent with the participant's hepatic impairment
For group 1 and 2 only: Medication and/or treatment regimens must have been stable (i.e., no dose adjustments) for at least 4 weeks prior to the screening period and should be kept stable until study completion Fluctuating treatment regimens may be considered for inclusion on a case-by-case basis if the underlying disease is under control in the opinion of the investigator and must be agreed to by both the investigator and the sponsor's medical monitor Further inclusion criteria apply.

Who cannot join

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
History of relevant orthostatic hypotension, repetitive fainting spells, or repetitive blackouts Further exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215

Other trials in United States

About this study

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)

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
Being tested: Zongertinib
Medical subject headings: Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZongertinibDrug
Also called BI 1810631, Hernexeos®
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

Study groups in NCT06692322
Study group	Role	What they receive
Child-Pugh A	Experimental	This arm comprised participants with mild hepatic impairment classified as Child-Pugh A, who received a single oral dose of 120 mg of zongertinib with 240 mL of water, following an overnight fast of at least 10 hrs. Receives: Drug: Zongertinib
Child-Pugh B	Experimental	This arm comprised participants with moderate hepatic impairment classified as Child-Pugh B, who received a single oral dose of 120 mg of zongertinib with 240 mL of water, following an overnight fast of at least 10 hrs. Receives: Drug: Zongertinib
Matched control	Experimental	This arm comprised all participants with normal hepatic function, individually matched to participants with hepatic impairment according to age, sex, and weight, and who 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. Receives: Drug: Zongertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
AUC0-∞ (area under the concentration-time curve of zongertinib in plasma over the time interval from 0 extrapolated to infinity) is reported.
Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effects 'degree of hepatic impairment' and 'matched pair' as fixed effects and was fitted separately for the 2 hepatic impaired groups: 1 model for the participants with mild hepatic impairment and their matched controls, and 1 model for the participants with moderate hepatic impairment and their matched controls. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.
Measured: Within 3 hours prior to and 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120 and 168 hours after administration of zongertinib.
Maximum Measured Concentration of Zongertinib in Plasma (Cmax)
Cmax (maximum measured concentration of zongertinib in plasma) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effects 'degree of hepatic impairment' and 'matched pair' as fixed effects and was fitted separately for the 2 hepatic impaired groups: 1 model for the participants with mild hepatic impairment and their matched controls, and 1 model for the participants with moderate hepatic impairment and their matched controls. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.
Measured: Within 3 hours prior to and 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120 and 168 hours after administration of zongertinib.

Secondary outcomes (1)

Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
AUC0-tz (area under the concentration-time curve of zongertinib in plasma over the time interval from 0 to the last quantifiable data point) is reported.
Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effects 'degree of hepatic impairment' and 'matched pair' as fixed effects and was fitted separately for the 2 hepatic impaired groups: 1 model for the participants with mild hepatic impairment and their matched controls, and 1 model for the participants with moderate hepatic impairment and their matched controls. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.
Measured: Within 3 hours prior to and 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120 and 168 hours after administration of zongertinib.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202520 Jun 2025

First posted18 Nov 2024
Study start15 Jan 2025
Primary completion20 Jun 2025
Study completion20 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Liver DiseasesStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06692322
Sponsor's protocol ID: 1479-0020
Other IDs: U1111-1307-9446
Status last verified: Aug 2026
First submitted: 15 Nov 2024
Last updated: 2 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Liver Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT06692322
Acronym / sponsor ID: 1479-0020
Conditions: Liver Diseases, Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 15 Jan 2025 (actual)
Primary completion: 20 Jun 2025 (actual)
Study completion: 20 Jun 2025 (actual)
First posted: 18 Nov 2024 (actual)
Results: Posted 2 Nov 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Child-Pugh A	Experimental	Drug: ZongertinibThis arm comprised participants with mild hepatic impairment classified as Child-Pugh A, who received a single oral dose of 120 mg of zongertinib with 240 mL of water, following an overnight fast of at least 10 hrs.
Child-Pugh B	Experimental	Drug: ZongertinibThis arm comprised participants with moderate hepatic impairment classified as Child-Pugh B, who received a single oral dose of 120 mg of zongertinib with 240 mL of water, following an overnight fast of at least 10 hrs.
Matched control	Experimental	Drug: ZongertinibThis arm comprised all participants with normal hepatic function, individually matched to participants with hepatic impairment according to age, sex, and weight, and who 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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:

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ZongertinibAlso: BI 1810631, Hernexeos®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	Drug	Child-Pugh A, Child-Pugh B, Matched control

Primary outcome

Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours prior to and 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120 and 168 hours after administration of zongertinib.
AUC0-∞ (area under the concentration-time curve of zongertinib in plasma over the time interval from 0 extrapolated to infinity) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effects 'degree of hepatic impairment' and 'matched pair' as fixed effects and was fitted separately for the 2 hepatic impaired groups: 1 model for the participants with mild hepatic impairment and their matched controls, and 1 model for the participants with moderate hepatic impairment and their matched controls. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.
Maximum Measured Concentration of Zongertinib in Plasma (Cmax)
Time frame: Within 3 hours prior to and 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120 and 168 hours after administration of zongertinib.
Cmax (maximum measured concentration of zongertinib in plasma) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effects 'degree of hepatic impairment' and 'matched pair' as fixed effects and was fitted separately for the 2 hepatic impaired groups: 1 model for the participants with mild hepatic impairment and their matched controls, and 1 model for the participants with moderate hepatic impairment and their matched controls. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.

1 secondary outcome

Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 hours prior to and 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120 and 168 hours after administration of zongertinib.

Results and safety

Results posted to the registry on 2 Nov 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Matched Control	13	13
Child-Pugh A	8	8
Child-Pugh B	8	8

Primary outcome: Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

Time frame: Within 3 hours prior to and 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120 and 168 hours after administration of zongertinib.. Geometric least squares mean (90% Confidence Interval). Unit: hours*nanomoles/Liter (h*nmol/L)

Measure	Child-Pugh A n = 8	Matched Control to Child-Pugh A n = 8	Child-Pugh B n = 8	Matched Control to Child-Pugh B n = 8
Value	31457.80 (26367.83 to 37530.15)	28490.38 (23880.08 to 33989.26)	20568.79 (16708.95 to 25318.74)	24689.75 (20058.33 to 30390.95)

Child-Pugh A vs Matched Control to Child-Pugh A: Ratio of adjusted geometric means (T/R): 110.42 (90% CI 86.03 to 141.72), Ratio of adjusted geometric means (Child
Child-Pugh B vs Matched Control to Child-Pugh B: Ratio of adjusted geometric means (T/R): 83.31 (90% CI 62.10 to 111.77)

Population analysed: Pharmacokinetic (PK) parameter analysis set (PKS) included all participants in the treated set who provided at least 1 primary or secondary PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS even if they contributed only 1 PK parameter value. Each participant with normal hepatic function could be matched to a participant in 1 or both hepatic impairment groups.

Primary outcome: Maximum Measured Concentration of Zongertinib in Plasma (Cmax)

Measure	Child-Pugh A n = 8	Matched Control to Child-Pugh A n = 8	Child-Pugh B n = 8	Matched Control to Child-Pugh B n = 8
Value	2335.43 (1992.21 to 2737.77)	2397.44 (2045.10 to 2810.45)	1322.88 (1077.50 to 1624.09)	2035.46 (1658.05 to 2498.89)

Child-Pugh A vs Matched Control to Child-Pugh A: Ratio of adjusted geometric means (T/R): 97.41 (90% CI 77.80 to 121.97), Ratio of adjusted geometric means (Child
Child-Pugh B vs Matched Control to Child-Pugh B: Ratio of adjusted geometric means (T/R): 64.99 (90% CI 48.63 to 86.86)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Serious Adverse Events and Other Adverse Events: From study drug administration until end of the residual effect period (i.e. 14 days), up to 336 hours. All-cause mortality: From drug administration till end of trial, up to 18 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Matched Control	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Child-Pugh A	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Child-Pugh B	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Zongertinib in people with Liver Diseases and Healthy, run by Boehringer Ingelheim at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (time frame: Within 3 hours prior to and 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120 and 168 hours after administration of zongertinib.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06692322.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.