Hepatic InsufficiencyPhase 1NCT07102095
A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose
A Phase 1 study testing Sevabertinib in people with Hepatic Insufficiency and Liver Diseases, run by Bayer at 2 sites in United States.
Trial summary
This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088). Sevabertinib is an experimental drug being developed to treat certain types of cancers that have specific genetic changes called HER2 mutations. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency, Liver Diseases, Pharmacokinetics
- What is being tested?
- Sevabertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jul 2025to 3 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent.
- Normal hepatic function or moderate hepatic impairment.
- Body weight of at least 50 kg and BMI of within the range 18 to 40 kg/m2 inclusive.
- Female, of non childbearing potential only. Females must not be pregnant or breastfeeding, and must be documented as of non-childbearing potential (WONCBP). A negative pregnancy test is required.
- Male study participants of reproductive potential must agree to use adequate contraception when sexually active from signing the Informed Consent Form (ICF) until at least 3 months after the last dose of study intervention, and refrain from sperm donation during study intervention and for 3 months after the last dose of study intervention.
- Signed ICF.
Show all 11Show fewer
- Documented liver disease with findings consistent with cirrhosis confirmed by histopathology, laparoscopy, fibroscan, CT, MRI, or ultrasound, AND
- Hepatic impairment (Child-Pugh B), AND
- Stable liver disease (i.e., same Child-Pugh class for at least 2 months prior to screening).
- Have normal hepatic function, AND
- Fulfil Arm A matching criteria (sex, age, and body weight).
Who cannot join
- Any existing relevant uncontrolled diseases of vital organs (e.g., heart, GI, pulmonary, or renal diseases), central nervous system (e.g., seizures), or other organs (e.g., uncontrolled diabetes mellitus [other than those related to hepatic impairment for the hepatically-impaired participants]) within 4 weeks prior to study intervention administration, including medically relevant infections and acute GI conditions (vomiting, diarrhea, and/or constipation).
- Known clinically relevant GI tract disorders (e.g., stomach ulcers, duodenal ulcers, GI bleeding, acute gastritis) or inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- Malignancy diagnosed or treated within the past 5 years (hepatocellular carcinoma within the past 2 years). Note: This does not include adequately-treated basal cell carcinoma or localized squamous cell carcinoma of the skin.
- Participants with primary or secondary biliary cirrhosis, or with sclerosing cholangitis.
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention will be affected.
- Renal impairment with an eGFR ≤40 mL/min according to the CKD-EPI equation.
Show all 29Show fewer
- Use of strong or moderate CYP3A4 inducers or inhibitors within 4 weeks or 5 half-lives prior to study intervention administration (whichever is longer) until last day of blood sampling for PK after study intervention administration.
- Use of drugs which may affect absorption, unless the drug is part of the mandatory dosing regimen for treatment of hepatic impairment or related conditions.
- Use of supplements or herbal remedies within 2 weeks prior to the first study intervention administration (except for vitamin supplementation).
- Use of anti-coagulant drugs.
- Positive alcohol blood/urine test at screening.
- Positive blood/urine drug screening indicating drug abuse (except for participants with hepatic insufficiency on an approved prescription for opioids or benzodiazepines who agree to withhold the use of opioids or benzodiazepines from 12 hours pre- and 12 hours post-intervention administration).
- Insufficiently controlled diabetes mellitus with HbA1c >10% within 6 months prior to study intervention administration.
- Consumption of food and beverages containing grapefruit, Seville orange, tangelo, or pomelos within 2 weeks prior to study intervention administration and up to the last PK sampling.
- Special diets preventing the participants from eating the standard meals during the study or unwillingness to eat the standard meals during the study.
- Use of recreational drugs, with the exception of cannabis (see below), carnitine products, anabolics, or high dose vitamins (except for medication against vitamin deficiency in hepatic impairment).
- Cannabis containing products should be stopped 5 days prior to study intervention and should not be used during the in-house period of the study until after participant discharge from the clinic.
- Smoking more than 10 cigarettes daily (including vaping equivalent to approximately 10 cigarettes daily), or, unwilling to refrain from smoking and/or vaping from 22:00 on the day prior to study intervention administration and on Day 1 until 12 hours after study intervention administration.
- Exclusion Criteria for Hepatic Impairment Group (Arm A) Medical Conditions
- Ascites qualitatively estimated as severe or requiring acute or frequent paracentesis (no emptying and/or albumin supplementation required within 30 days prior to Day 1 [or at least within 14 days], or during the course of the study, as judged by the investigator), or a recent history of paracentesis.
- Encephalopathy of Grade >2. Examinations
- ALP ≥4 × ULN.
- AST, ALT or GGT ≥4 × ULN.
- Platelet count <60 × 10^9/L.
- Hemoglobin <9 g/dL.
- Serum albumin <2 g/dL.
- INR >2.3.
- Increase of liver enzymes (e.g., ALT, AST, GGT, or total bilirubin) above ULN.
- Increase of lipase and amylase (except isolated marginal increases of lipase or amylase to account for variability of the parameters, and the participant is asymptomatic and has no other laboratory changes assuming disease based on medical judgment).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Pharmacology of Miami - Oncology
Miami, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-label, Single-dose Study to Assess the Influence of Hepatic Impairment on the Pharmacokinetics of of Sevabertinib (BAY 2927088)
This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088).
Sevabertinib is an experimental drug being developed to treat certain types of cancers that have specific genetic changes called HER2 mutations. This includes lung cancer, tumors that have spread to other parts of the body (metastatic), and tumors that cannot be removed with surgery (unresectable). Before this medicine can be given to cancer patients with liver problems, researchers need to understand how liver disease might change the way the body handles the drug.
Read more
The study will include about 20 people divided into two groups: 10 people with moderate liver problems (called Child-Pugh B liver impairment) and 10 healthy people with normal liver function. The healthy volunteers will be matched to the liver patients by age, sex, and weight to make fair comparisons.
All participants will take a single 20 mg dose of sevabertinib by mouth and stay in the research clinic for 5 days. During this time, researchers will take blood samples at specific times to measure how much drug is in the blood and how long it stays in the body. They will also monitor participants closely for any side effects.
The main goal is to see if people with liver problems have different drug levels in their blood compared to healthy people. This information will help doctors determine if cancer patients with liver disease need different doses of sevabertinib to be safe and effective.
The study will also look at the safety and tolerability of sevabertinib in both groups. Participants will have follow-up visits to ensure their continued health and safety.
This research is important because many cancer patients also have liver problems, and understanding how liver disease affects this new cancer treatment will help ensure it can be used safely and effectively in all patients who might benefit from it.
- Being tested
- Sevabertinib
- Medical subject headings
- Hepatic Insufficiency, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevabertinibDrug
Single oral dose of 20 mg sevabertinib administered as 2 x 10 mg film-coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Moderate Hepatic Impairment | Experimental | Approximately 10 participants with moderate impaired hepatic function (Child-Pugh B) to achieve approximately 8 evaluable participants Receives: Drug: Sevabertinib |
| Arm B: Normal Hepatic Function | Experimental | Approximately 10 matched control participants for Arm A with normal hepatic function Receives: Drug: Sevabertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve (AUC) of sevabertinib
To assess the influence of hepatic impairment on sevabertinib exposure. AUC from time zero to the last data point larger than the lower limit of quantification (LLOQ) (AUC(0-tlast) and the unbound AUC(0-tlast) will be used as the main parameters if AUC cannot be reliably determined in all participants.
Measured: 0-96 hours post-dose
Unbound area under plasma concentration-time curve AUC (AUCu) of sevabertinib
To assess the influence of hepatic impairment on sevabertinib exposure. AUC from time zero to the last data point larger than the lower limit of quantification (LLOQ) (AUC(0-tlast) and the unbound AUC(0-tlast) will be used as the main parameters if AUC cannot be reliably determined in all participants.
Measured: 0-96 hours post-dose
Maximum observed drug concentration (Cmax) of sevabertinib in plasma
To assess the influence of hepatic impairment on sevabertinib exposure.
Measured: 0-96 hours post-dose
Unbound Cmax (Cmax,u) of sevabertinib in plasma
To assess the influence of hepatic impairment on sevabertinib exposure.
Measured: 0-96 hours post-dose
Secondary outcomes (1)
Incidence and severity of adverse events
Measured: From signing of informed consent form (ICF) until follow-up visit (approximately 2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start24 Jul 2025
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102095
- Sponsor's protocol ID
- 22988
- Status last verified
- Feb 2026
- First submitted
- 18 Jul 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-dose Study to Assess the Influence of Hepatic Impairment on the Pharmacokinetics of of Sevabertinib (BAY 2927088)
- ClinicalTrials.gov ID
- NCT07102095
- Acronym / sponsor ID
- 22988
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088).
Sevabertinib is an experimental drug being developed to treat certain types of cancers that have specific genetic changes called HER2 mutations. This includes lung cancer, tumors that have spread to other parts of the body (metastatic), and tumors that cannot be removed with surgery (unresectable). Before this medicine can be given to cancer patients with liver problems, researchers need to understand how liver disease might change the way the body handles the drug.
The study will include about 20 people divided into two groups: 10 people with moderate liver problems (called Child-Pugh B liver impairment) and 10 healthy people with normal liver function. The healthy volunteers will be matched to the liver patients by age, sex, and weight to make fair comparisons.
All participants will take a single 20 mg dose of sevabertinib by mouth and stay in the research clinic for 5 days. During this time, researchers will take blood samples at specific times to measure how much drug is in the blood and how long it stays in the body. They will also monitor participants closely for any side effects.
The main goal is to see if people with liver problems have different drug levels in their blood compared to healthy people. This information will help doctors determine if cancer patients with liver disease need different doses of sevabertinib to be safe and effective.
The study will also look at the safety and tolerability of sevabertinib in both groups. Participants will have follow-up visits to ensure their continued health and safety.
This research is important because many cancer patients also have liver problems, and understanding how liver disease affects this new cancer treatment will help ensure it can be used safely and effectively in all patients who might benefit from it.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Moderate Hepatic Impairment | Experimental | Drug: SevabertinibApproximately 10 participants with moderate impaired hepatic function (Child-Pugh B) to achieve approximately 8 evaluable participants |
| Arm B: Normal Hepatic Function | Experimental | Drug: SevabertinibApproximately 10 matched control participants for Arm A with normal hepatic function |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent.
- Normal hepatic function or moderate hepatic impairment.
- Body weight of at least 50 kg and BMI of within the range 18 to 40 kg/m2 inclusive.
- Female, of non childbearing potential only. Females must not be pregnant or breastfeeding, and must be documented as of non-childbearing potential (WONCBP). A negative pregnancy test is required.
- Male study participants of reproductive potential must agree to use adequate contraception when sexually active from signing the Informed Consent Form (ICF) until at least 3 months after the last dose of study intervention, and refrain from sperm donation during study intervention and for 3 months after the last dose of study intervention.
Key exclusion criteria (29 listed)
- Any existing relevant uncontrolled diseases of vital organs (e.g., heart, GI, pulmonary, or renal diseases), central nervous system (e.g., seizures), or other organs (e.g., uncontrolled diabetes mellitus [other than those related to hepatic impairment for the hepatically-impaired participants]) within 4 weeks prior to study intervention administration, including medically relevant infections and acute GI conditions (vomiting, diarrhea, and/or constipation).
- Known clinically relevant GI tract disorders (e.g., stomach ulcers, duodenal ulcers, GI bleeding, acute gastritis) or inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- Malignancy diagnosed or treated within the past 5 years (hepatocellular carcinoma within the past 2 years). Note: This does not include adequately-treated basal cell carcinoma or localized squamous cell carcinoma of the skin.
- Participants with primary or secondary biliary cirrhosis, or with sclerosing cholangitis.
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention will be affected.
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 |
|---|---|---|
| SevabertinibSingle oral dose of 20 mg sevabertinib administered as 2 x 10 mg film-coated tablets | Drug | Arm A: Moderate Hepatic Impairment, Arm B: Normal Hepatic Function |
Primary outcome
Area under plasma concentration-time curve (AUC) of sevabertinib
Time frame: 0-96 hours post-dose
To assess the influence of hepatic impairment on sevabertinib exposure. AUC from time zero to the last data point larger than the lower limit of quantification (LLOQ) (AUC(0-tlast) and the unbound AUC(0-tlast) will be used as the main parameters if AUC cannot be reliably determined in all participants.
Unbound area under plasma concentration-time curve AUC (AUCu) of sevabertinib
Time frame: 0-96 hours post-dose
To assess the influence of hepatic impairment on sevabertinib exposure. AUC from time zero to the last data point larger than the lower limit of quantification (LLOQ) (AUC(0-tlast) and the unbound AUC(0-tlast) will be used as the main parameters if AUC cannot be reliably determined in all participants.
Maximum observed drug concentration (Cmax) of sevabertinib in plasma
Time frame: 0-96 hours post-dose
To assess the influence of hepatic impairment on sevabertinib exposure.
Unbound Cmax (Cmax,u) of sevabertinib in plasma
Time frame: 0-96 hours post-dose
To assess the influence of hepatic impairment on sevabertinib exposure.
1 secondary outcome
Incidence and severity of adverse events
Time frame: From signing of informed consent form (ICF) until follow-up visit (approximately 2 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No. Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Related trials for Hepatic Insufficiency
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Recruiting
SPYRAL GEMINI Pilot Study
Hypertension, Vascular Diseases
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruitingPhase 4
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
Liver Cirrhosis, Sleep Disturbance
Not yet recruiting
Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy
Liver Cirrhosis, Hepatic Encephalopathy (HE)
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sevabertinib in people with Hepatic Insufficiency and Liver Diseases, run by Bayer at 2 sites 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 11 inclusion and 29 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 plasma concentration-time curve (AUC) of sevabertinib (time frame: 0-96 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2026.