A Study to Investigate the Effects of Impaired Hepatic Function on Velzatinib

October 1, 2026 updated by: GlaxoSmithKline

A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of Velzatinib in Participants With Hepatic Impairment Compared to Healthy Participants

This study evaluates the pharmacokinetics (PK), safety, and tolerability of velzatinib in participants with mild, moderate, and severe hepatic impairment (HI) and participants with normal hepatic function.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant is 18 to 80 years of age, inclusive, at the time of signing the Informed consent form (ICF).
  • Participant has stable hepatic function that can be classified into 1 of 4 groups according to the Child-Pugh and National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG) classification.
  • Participant has stable hepatic function (i.e., no clinically significant change in status according to the investigator's clinical judgment within the preceding 14 days [e.g., no worsening of clinical signs of HI, or no worsening of total bilirubin or prothrombin by more than 50 percent]) and those needing treatment are on stable doses of medication.
  • Participants with HI may be taking medications, which in the opinion of the investigator, are believed to be therapeutic but do not affect study intervention absorption, distribution, metabolism, excretion (ADME).
  • Has no clinically significant and unstable cardiovascular or endocrine findings, except as expected by their pre-existing hepatic condition in the investigator's opinion.
  • Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. Participants with chronic disorders such as hypertension and diabetes mellitus can be enrolled, provided those disorders are stable and adequately controlled, but otherwise participants should be considered healthy for their age.

Exclusion Criteria:

  • Participant has a history or evidence of clinically significant hematologic, dermatologic, neurologic, pulmonary, immunologic or atopic (except seasonal allergies), or endocrine disease, or psychiatric disorder (such as psychosis, delusions, or schizophrenia), or other abnormality, that may impact the ability of the participant to participate or potentially confound the study results, or that, in the investigator's opinion, makes the participant unsuitable for the study.
  • Semi-supine blood pressure (BP) outside the ranges of 100 to 140 millimeters of mercury (mmHg) for systolic BP and 50 to 90 mmHg for diastolic BP (BP to be measured in triplicate), or a semi-supine pulse rate outside the range of 45 to 90 beats per minute (bpm).
  • Participant has symptoms arising from orthostatic hypotension such that there is a decrease in systolic BP of greater than or equal to (>=) 20 mmHg or in diastolic BP of >=10 mmHg, or pulse rate increase >=30 bpm.
  • Participant has history of extrahepatic disorders possibly related to etiology of cirrhosis (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, uncontrolled hypertension) (for participants with hepatic impairment).
  • Participant has a history of liver or other solid organ transplant including transjugular intrahepatic portosystemic shunt (TIPS) placement (for participants with hepatic impairment).
  • Participant has evidence of acute viral hepatitis within 30 days before dosing with study drug.( for participants with hepatic impairment)
  • Hepatitis B surface antigen (HBsAg) positive participants are allowed to be enrolled if Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) is below 1000 copies per milliliter in the plasma, at Screening. Participants with HI who are positive for hepatitis C virus antibodies (HCVAb) can be enrolled but must not have detectable hepatitis C virus antibodies (HCV) Ribonucleic acid (RNA) on reflex testing, at Screening (for participants with hepatic impairment).
  • The participant has a positive test result for HBsAg or Hepatitis B core antibody (HBcAb) at Screening or within 3 months prior to administration of the study intervention dose (for participants with normal hepatic function).
  • The participant has a positive hepatitis C antibody test result at Screening or within 3 months prior to the administration of the study intervention dose (for participants with normal hepatic function).
  • Participant has regular alcohol consumption within 6 months prior to the study, defined as an average weekly intake of >14 units for males and females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 milliliters [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
  • Participant has clinically significant cardiac disease, including second- or third-degree atrioventricular block, clinically significant tachyarrhythmias, or atrial fibrillation/flutter.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Participants with mild hepatic impairment receiving Velzatinib
Drug: Velzatinib

Velzatinib will be administered

Other Names:
  • GSK6042981/IDRX-42
Experimental: Participants with moderate hepatic impairment receiving Velzatinib
Drug: Velzatinib

Velzatinib will be administered

Other Names:
  • GSK6042981/IDRX-42
Experimental: Participants with severe hepatic impairment receiving Velzatinib
Drug: Velzatinib

Velzatinib will be administered

Other Names:
  • GSK6042981/IDRX-42
Active Comparator: Participants with normal hepatic function receiving Velzatinib
Drug: Velzatinib

Velzatinib will be administered

Other Names:
  • GSK6042981/IDRX-42

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum plasma concentration (Cmax)
Time Frame: Up to 936 hours
Up to 936 hours
Area under the plasma concentration-time curve extrapolated to infinity AUC(0-inf)
Time Frame: Up to 936 hours
Up to 936 hours
Maximum plasma unbound concentration (Cmax,u)
Time Frame: Up to 936 hours
Up to 936 hours
Area under the unbound plasma concentration-time curve extrapolated to infinity (AUC[0-inf],u)
Time Frame: Up to 936 hours
Up to 936 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to maximum observed plasma drug concentration (Tmax)
Time Frame: Up to 936 hours
Up to 936 hours
Area under the plasma drug concentration-time curve from time 0 to 48 hours post-dose administration (AUC[0-48])
Time Frame: Up to 48 hours
Up to 48 hours
Area under the plasma drug concentration-time curve from time 0 to time of the last quantifiable concentration (AUC[0-last])
Time Frame: Up to 936 hours
Up to 936 hours
Terminal elimination rate constant
Time Frame: Up to 936 hours
Up to 936 hours
Apparent terminal phase half-life (t1/2)
Time Frame: Up to 936 hours
Up to 936 hours
Apparent clearance (CL/F)
Time Frame: Up to 936 hours
Up to 936 hours
Apparent volume of distribution (Vz/F)
Time Frame: Up to 936 hours
Up to 936 hours
Regression coefficient Between Pharmacokinetic Parameters and Measures of Hepatic Function
Time Frame: Up to 936 hours

The relationship between PK parameters and measures of hepatic function will be evaluated using regression analyses. Regression coefficients will be summarized to describe the direction and magnitude of the relationship. A positive regression coefficient indicates that an increase in the hepatic function parameter is associated with an increase in the PK parameter, whereas a negative regression coefficient indicates that an increase in the hepatic function parameter is associated with a decrease in the PK parameter. A regression coefficient close to zero suggests little or no linear relationship between the hepatic-function measure and the PK parameter. Unit of measure: unitless (will be reported as a regression coefficient).
Up to 936 hours
Number of participants with adverse events (AEs) and serious adverse events (SAEs) by severity
Time Frame: Up to 40 days
Up to 40 days
Number of participants with clinically significant changes in clinical laboratory parameters, physical examinations, Electrocardiogram (ECG) and vital signs
Time Frame: Up to 40 days
Up to 40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 301039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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