Study of Vorasidenib in severe liver disease and healthy volunteers
Treatments studied
This trial tests how the drug vorasidenib behaves in people with severe liver problems compared to healthy volunteers. It helps doctors understand if the drug needs different dosing for patients with liver disease.
Summary written for real people, not researchers, by Clin2.
Who can take part
- For liver disease group: You must have cirrhosis with severe liver impairment (Child-Pugh score 10–15) and be medically stable for at least 1 month.
- For liver disease group: You cannot have had worsening of hepatic encephalopathy (confusion from liver issues) in the past 6 months.
- For healthy volunteer group: You must have normal liver function and match a liver disease participant by age, sex, race, weight, and smoking habits.
- For both groups: You cannot be pregnant, breastfeeding, or planning pregnancy within 90 days of taking the drug.
- For both groups: You must avoid grapefruit, alcohol, caffeine, and certain other foods/beverages before and during the study.
- For both groups: You cannot have had cancer (except some skin cancers) in the last 5 years.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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