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

1 de outubro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

40

Estágio

  • Fase 1

Acesso expandido

Disponível fora do ensaio clínico. Consulte registro de acesso expandido.

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Participants with mild hepatic impairment receiving Velzatinib

Velzatinib will be administered

Outros nomes:
  • GSK6042981/IDRX-42
Experimental: Participants with moderate hepatic impairment receiving Velzatinib

Velzatinib will be administered

Outros nomes:
  • GSK6042981/IDRX-42
Experimental: Participants with severe hepatic impairment receiving Velzatinib

Velzatinib will be administered

Outros nomes:
  • GSK6042981/IDRX-42
Comparador Ativo: Participants with normal hepatic function receiving Velzatinib

Velzatinib will be administered

Outros nomes:
  • GSK6042981/IDRX-42

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Maximum plasma concentration (Cmax)
Prazo: Up to 936 hours
Up to 936 hours
Area under the plasma concentration-time curve extrapolated to infinity AUC(0-inf)
Prazo: Up to 936 hours
Up to 936 hours
Maximum plasma unbound concentration (Cmax,u)
Prazo: Up to 936 hours
Up to 936 hours
Area under the unbound plasma concentration-time curve extrapolated to infinity (AUC[0-inf],u)
Prazo: Up to 936 hours
Up to 936 hours

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Time to maximum observed plasma drug concentration (Tmax)
Prazo: 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])
Prazo: 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])
Prazo: Up to 936 hours
Up to 936 hours
Terminal elimination rate constant
Prazo: Up to 936 hours
Up to 936 hours
Apparent terminal phase half-life (t1/2)
Prazo: Up to 936 hours
Up to 936 hours
Apparent clearance (CL/F)
Prazo: Up to 936 hours
Up to 936 hours
Apparent volume of distribution (Vz/F)
Prazo: Up to 936 hours
Up to 936 hours
Regression coefficient Between Pharmacokinetic Parameters and Measures of Hepatic Function
Prazo: 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
Prazo: 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
Prazo: Up to 40 days
Up to 40 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Diretor de estudo: GSK Clinical Trials, GlaxoSmithKline

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

10 de novembro de 2026

Conclusão Primária (Estimado)

25 de abril de 2028

Conclusão do estudo (Estimado)

25 de abril de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

1 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de outubro de 2026

Primeira postagem (Real)

6 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de outubro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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

Prazo de Compartilhamento de 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.

Critérios de acesso de compartilhamento 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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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