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

1. oktober 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Fase 1

Utvidet tilgang

Tilgjengelig utenfor den kliniske utprøvingen. Se utvidet tilgangspost.

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Participants with mild hepatic impairment receiving Velzatinib

Velzatinib will be administered

Andre navn:
  • GSK6042981/IDRX-42
Eksperimentell: Participants with moderate hepatic impairment receiving Velzatinib

Velzatinib will be administered

Andre navn:
  • GSK6042981/IDRX-42
Eksperimentell: Participants with severe hepatic impairment receiving Velzatinib

Velzatinib will be administered

Andre navn:
  • GSK6042981/IDRX-42
Aktiv komparator: Participants with normal hepatic function receiving Velzatinib

Velzatinib will be administered

Andre navn:
  • GSK6042981/IDRX-42

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Studieleder: GSK Clinical Trials, GlaxoSmithKline

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

10. november 2026

Primær fullføring (Antatt)

25. april 2028

Studiet fullført (Antatt)

25. april 2028

Datoer for studieregistrering

Først innsendt

1. oktober 2026

Først innsendt som oppfylte QC-kriteriene

1. oktober 2026

Først lagt ut (Faktiske)

6. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. oktober 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere