- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07859735
A Study to Investigate the Effects of Impaired Hepatic Function on Velzatinib
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Accesso esteso
Contatti e Sedi
Contatto studio
- Nome: US GSK Clinical Trials Call Center
- Numero di telefono: 877-379-3718
- Email: GSKClinicalSupportHD@gsk.com
Backup dei contatti dello studio
- Nome: EU GSK Clinical Trials Call Center
- Numero di telefono: +44 (0) 20 89904466
- Email: GSKClinicalSupportHD@gsk.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Participants with mild hepatic impairment receiving Velzatinib
|
Velzatinib will be administered
Altri nomi:
|
|
Sperimentale: Participants with moderate hepatic impairment receiving Velzatinib
|
Velzatinib will be administered
Altri nomi:
|
|
Sperimentale: Participants with severe hepatic impairment receiving Velzatinib
|
Velzatinib will be administered
Altri nomi:
|
|
Comparatore attivo: Participants with normal hepatic function receiving Velzatinib
|
Velzatinib will be administered
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Maximum plasma concentration (Cmax)
Lasso di tempo: Up to 936 hours
|
Up to 936 hours
|
|
Area under the plasma concentration-time curve extrapolated to infinity AUC(0-inf)
Lasso di tempo: Up to 936 hours
|
Up to 936 hours
|
|
Maximum plasma unbound concentration (Cmax,u)
Lasso di tempo: Up to 936 hours
|
Up to 936 hours
|
|
Area under the unbound plasma concentration-time curve extrapolated to infinity (AUC[0-inf],u)
Lasso di tempo: Up to 936 hours
|
Up to 936 hours
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time to maximum observed plasma drug concentration (Tmax)
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: Up to 936 hours
|
Up to 936 hours
|
|
|
Terminal elimination rate constant
Lasso di tempo: Up to 936 hours
|
Up to 936 hours
|
|
|
Apparent terminal phase half-life (t1/2)
Lasso di tempo: Up to 936 hours
|
Up to 936 hours
|
|
|
Apparent clearance (CL/F)
Lasso di tempo: Up to 936 hours
|
Up to 936 hours
|
|
|
Apparent volume of distribution (Vz/F)
Lasso di tempo: Up to 936 hours
|
Up to 936 hours
|
|
|
Regression coefficient Between Pharmacokinetic Parameters and Measures of Hepatic Function
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 40 days
|
Up to 40 days
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: GSK Clinical Trials, GlaxoSmithKline
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 301039
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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
Periodo di condivisione 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.
Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .