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A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function
Code de protocole Servier:
PKH-95032-008
Sponsor:
Institut de Recherches Internationales Servier
Identifiant Clinicaltrials.gov:
NCT05674474
Trouver un site de recrutement
Comment participer à cette étude
Si vous pensez être éligible pour cette étude (voir
ci-dessous), vous pouvez identifier le site le plus proche de chez vous et le contacter directement. Si vous ne trouvez pas de site près de chez vous, veuillez contacter l'Institut de Recherches Internationales Servier (I.R.I.S.).
critères d'éligibilité
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Ceux-ci comprennent les critères d'inclusion et les critères d'exclusion. Parmi ces critères, on peut citer l'état de santé général d'une personne ou les traitements antérieurs qu'elle a suivis.
Nom:
Institut de Recherches Internationales Servier, Département des études cliniques
Numéro de téléphone:
+33 1 55 72 60 00
L'étude a 1 centre
Description de l'étude
The primary purpose of this study is to estimate the effect of moderate or mild hepatic impairment on the pharmacokinetic (PK) profile of a single oral dose of 20 mg vorasidenib in participants with hepatic impairment relative to healthy matched control participants with normal hepatic function.
Titre officiel: A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a 20-mg Dose of Vorasidenib in Subjects With Moderate or Mild Hepatic Impairment and Matched Subjects With Normal Hepatic Function
Indications
Hepatic Impairment
Interventions / Traitements
Le ou les traitements administrés aux participants à l'étude.
- Vorasidenib
Autres numéros d'identification
Autres numéros d'identification sous lesquels l'étude peut être connue.
- PKH-95032-008
Critères d'éligibilité
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Ceux-ci comprennent les critères d'inclusion et les critères d'exclusion. Parmi ces critères, on peut citer l'état de santé général d'une personne ou les traitements antérieurs qu'elle a suivis.
Age éligible pour l’étude
18 ans à 70 ans
(Adulte, Adulte plus âgé)
Sexe
Homme/FemmeAccepte les volontaires en bonne santé
Oui- * Have a body mass index of 18 to 40 kilograms per square meter (kg/m^2).
- * Female participants of childbearing potential must use 2 effective methods of birth control during the study and for 90 days after the last dose of vorasidenib or be surgically sterile, or postmenopausal.
- * Male participants with female partners of childbearing potential must be sterile, or willing to use 2 effective methods of birth control from Screening until at least 90 days after the last dose of the study drug, or practice abstinence during the study.
- * Non-smoker or uses ≤10 cigarettes per day as judged by the investigator.
- * Agree to comply with all protocol requirements for the duration of the study.
- * Able to provide written informed consent prior to any procedure required by the study.
- * Have normal hepatic function.
- * Have chronic (more than 6 months) and stable hepatic impairment (i.e., no acute episodes of illness within 30 days before Screening due to deterioration of hepatic function) as assessed by a Child-Pugh classification score of moderate (7 to 9 points) and, if Stage 2 enrolls, mild (5 to 6 points).
- * The subject has grade 0 or grade 1 hepatic encephalopathy, considered stable per investigator assessment, without exacerbation within the 6 months prior to Screening.
- * The subject has a QTcF of ≤480 msec.
- * Have a history or clinical manifestations of a significant neurological, renal, cardiovascular, gastrointestinal, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
- * Have a history (within 5 years) or presence of malignancy, except for adequately treated basal cell and squamous cell carcinoma of the skin.
- * The subject is a woman of childbearing potential who is pregnant, lactating, or planning to become pregnant within 90 days after the last dose of study drug or the subject is on oral contraceptive pills within 14 days or 5 half-lives (whichever is longer) prior to the first dose administration and during the study.
- * Have received any vaccine or used any prescription (excluding hormone replacement therapy) or over-the-counter medications, including herbal or nutritional supplements, within 30 days before the first dose of the study drug.
- * Have a positive test result for hepatitis B surface antigen or antibodies to hepatitis C virus.
- * Have a positive test result for the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- * Have a positive test result for human immunodeficiency virus (HIV) types 1 or 2 antibodies.
- * Have used strong or moderate CYP1A2 inhibitors and/or inducers within 14 days or 5 half-lives, whichever is longer, prior to the first dose administration. .
- * Have used any gastric acid reducing agents (eg, proton-pump inhibitors, H2-receptor antagonists, antacids) or drugs that can prolong the QT interval for 28 days or 5 drug half-lives (whichever is longer) prior to the first dosing and throughout the study
- * Have a history of severe and/or uncontrolled ventricular arrhythmias or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome).
- * Have a history of alcoholism or drug abuse within 3 months before Screening or excessive alcohol consumption.
- * Unable or unwilling to abstain from recreational drugs, alcohol, caffeine, xanthine-containing beverages or food (e.g., coffee, tea, chocolate, and caffeinated sodas, colas), grapefruit, grapefruit juice, Seville oranges, or products containing any of these, from 48 hours prior to study drug dosing until discharge.
- * Involved in strenuous activity (i.e., >30 minutes [min] per day) or contact sports within 48 hours of the first dose of the study drug or during the study.
- * Have a history of relevant drug and/or food allergies (i.e., allergy to drugs with the same class effect as vorasidenib or any excipients, or any significant food allergy).
- * Have received study drug in another investigational study within 30 days of dosing.
- * Have ascites that requires paracentesis every 4 weeks or less frequently.
- * Have evidence of hepatorenal syndrome or hepatic encephalopathy.
- * Have a history of incipient/planned liver transplantation within 6 months of Screening or have received a liver transplant.
- * Have amylase and/or lipase levels ≥3 x upper limit of normal (ULN). Presence of 8 x ULN elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin and international normalized ratio (INR) of 3.5 for the hepatic impaired group.
Comment l'étude est-elle conçue ?
Allocation
Comment les participants sont répartis dans différents groupes. La répartition peut être aléatoire (randomisée) ou prédéterminée (non randomisée). Randomisée signifie que les participants sont répartis de manière aléatoire dans leur groupe/branche.
Modèle d'étude interventionnelle
Comment les traitements sont administrés et testés dans le cadre d'une étude.
Parallèle
Une étude parallèle compare deux groupes ou plus en même temps, chaque groupe recevant un traitement différent. Les chercheurs comparent ensuite les résultats afin de déterminer quel traitement est le plus efficace.
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Expérimental:
Group A: Normal Hepatic Function
Participants with normal hepatic function will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1.
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Traitement:
Vorasidenib
Administered orally as tablets.
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Expérimental:
Group B: Moderate or Mild Hepatic Impairment
Stage 1: Participants with moderate hepatic impairment (Child-Pugh \[C-P\] Class B, score of 7 to 9) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1.
Stage 2: Participants with mild hepatic impairment (C-P Class A, score of 5 to 6) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Stage 2 will be conducted if a clinically meaningful increase in exposure of vorasidenib is observed in participants with moderate hepatic impairment in Stage 1.
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Traitement:
Vorasidenib
Administered orally as tablets.
Mots clés
Fournis par Servier
Vorasidenib