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Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants
Code de protocole Servier:
S95032-223
Sponsor:
Institut de Recherches Internationales Servier (I.R.I.S.)
Identifiant Clinicaltrials.gov:
NCT07250633
Trouver un site de recrutement
Nom:
Institut de Recherches Internationales Servier, Département des études cliniques
Numéro de téléphone:
+33 1 55 72 60 00
Description de l'étude
The objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of one dose of vorasidenib in participants with severe impaired hepatic function compared to participants with normal hepatic function. The study includes a screening phase, a treatment period, and a follow-up period. During the first part of the treatment period, from Day 1 through Day 4, participants will remain in-house in the clinical research unit. In the second part of the treatment period, from Day 5 through Day 43, participants can go home but may also choose to remain in-house. The entire study, including screening and follow-up, will last up to 77 days. Participants may undergo blood tests, heart tests (electrocardiogram (ECG)), vital sign checks, and physical exams.
Titre officiel: A Phase 1, Open-Label, Non-randomized, Single Dose, Safety, Tolerability, and Pharmacokinetic Study of Vorasidenib Administered to Participants With Severe Hepatic Impairment and Matched-Participants With Normal Hepatic Function
Indications
Severe Hepatic Impairment
Normal Hepatic Function
Interventions / Traitements
Le ou les traitements administrés aux participants à l'étude.
- Vorasidenib 20mg
Autres numéros d'identification
Autres numéros d'identification sous lesquels l'étude peut être connue.
- S95032-223
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 75 ans
(Adulte, Adulte plus âgé)
Sexe
Homme/FemmeAccepte les volontaires en bonne santé
Oui- Participants with hepatic impairment:
- * Diagnosis of cirrhosis due to parenchymal liver disease
- * Considered to have a Child-Pugh score of 10 to 15, consistent with severe HI, and a documented medical history of liver disease. Participants must be clinically stable (no acute episodes of illness due to deterioration in hepatic function) for at least 1 month prior to screening and are likely to remain stable throughout the study.
- * Grade 0 or Grade 1 hepatic encephalopathy considered stable per Investigator assessment without exacerbation within the 6 months prior to screening.
- * Currently on a stable medication regimen, defined as not starting new drug(s) or significantly changing drug dosage(s) within 14 days preceding Day 1.
- * Non-hepatic abnormal laboratory values must be not clinically significant as judged by the Investigator (or designee) and the study medical monitor.
- * Anemia secondary to hepatic disease is acceptable if hemoglobin is ≥ 9 g/dL and anemia symptoms are not clinically significant. Platelet count must be ≥ 35,000 platelets.
- * QT interval corrected for heart rate using Fridericia's formula (QTcF) of ≤ 480 msec.
- Matched-control participants:
- * Healthy, with normal hepatic function with a Child-Pugh score below 5.
- * Resting blood pressure of 90 to 140 mmHg (systolic) and 40 to 90 mmHg (diastolic).
- * QTcF of ≤ 450 msec.
- * Participant must match hepatically impaired participants with respect to sex, race, age (±10 years), smoking status (smoke or vape ≤ 10 cigarettes/day), and body mass index (±20%).
- * Women of childbearing potential (WOCBP) who are pregnant, lactating, or planning to become pregnant within 90 days after the dose of vorasidenib.
- * The participant is using hormonal contraceptives
- * Use of any other investigational drug or device within 30 days (or 5 half-lives if known, whichever is longer) before the dose of vorasidenib
- * Consumption of any nutrients known to modulate CYP450 enzymes activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, Seville [blood] orange products) within 14 days before vorasidenib administration.
- * Consumption of alcohol-containing foods or beverages or caffeine- or xanthine-containing foods or beverages (including, but not limited to, teas [including decaffeinated teas], coffees [including decaffeinated coffees], colas [including decaffeinated colas], energy drinks, gum containing caffeine, and chocolate (including foods and beverages containing chocolate) within 48 hours prior to admission
- * Any history (within 5 years prior to screening) or presence of malignancy, except for adequately treated basal cell and squamous cell carcinoma of the skin
- * History within the previous 12 months of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 12 oz beer, 5 oz wine, or 1.5 oz spirits)
- * In the opinion of the Investigator, the participant is not suitable for entry into the study
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:
Participants with Severe Hepatic Impairment (HI)
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Traitement:
Vorasidenib 20mg
Vorasidenib 20mg will be taken by mouth on Day 1
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Expérimental:
Matched-Participants with Normal Hepatic Function
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Traitement:
Vorasidenib 20mg
Vorasidenib 20mg will be taken by mouth on Day 1