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

1 octobre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • La phase 1

Accès étendu

Disponible en dehors de l'essai clinique. Voir enregistrement d'accès étendu.

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Participants with mild hepatic impairment receiving Velzatinib

Velzatinib will be administered

Autres noms:
  • GSK6042981/IDRX-42
Expérimental: Participants with moderate hepatic impairment receiving Velzatinib

Velzatinib will be administered

Autres noms:
  • GSK6042981/IDRX-42
Expérimental: Participants with severe hepatic impairment receiving Velzatinib

Velzatinib will be administered

Autres noms:
  • GSK6042981/IDRX-42
Comparateur actif: Participants with normal hepatic function receiving Velzatinib

Velzatinib will be administered

Autres noms:
  • GSK6042981/IDRX-42

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Maximum plasma concentration (Cmax)
Délai: Up to 936 hours
Up to 936 hours
Area under the plasma concentration-time curve extrapolated to infinity AUC(0-inf)
Délai: Up to 936 hours
Up to 936 hours
Maximum plasma unbound concentration (Cmax,u)
Délai: Up to 936 hours
Up to 936 hours
Area under the unbound plasma concentration-time curve extrapolated to infinity (AUC[0-inf],u)
Délai: Up to 936 hours
Up to 936 hours

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time to maximum observed plasma drug concentration (Tmax)
Délai: 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])
Délai: 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])
Délai: Up to 936 hours
Up to 936 hours
Terminal elimination rate constant
Délai: Up to 936 hours
Up to 936 hours
Apparent terminal phase half-life (t1/2)
Délai: Up to 936 hours
Up to 936 hours
Apparent clearance (CL/F)
Délai: Up to 936 hours
Up to 936 hours
Apparent volume of distribution (Vz/F)
Délai: Up to 936 hours
Up to 936 hours
Regression coefficient Between Pharmacokinetic Parameters and Measures of Hepatic Function
Délai: 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
Délai: 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
Délai: Up to 40 days
Up to 40 days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Directeur d'études: GSK Clinical Trials, GlaxoSmithKline

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

10 novembre 2026

Achèvement primaire (Estimé)

25 avril 2028

Achèvement de l'étude (Estimé)

25 avril 2028

Dates d'inscription aux études

Première soumission

1 octobre 2026

Première soumission répondant aux critères de contrôle qualité

1 octobre 2026

Première publication (Réel)

6 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 octobre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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