Condition: Severe Hepatic Impairment · Normal Hepatic Function · Sponsor: Institut de Recherches Internationales Servier (I.R.I.S.)
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.
This description comes directly from the study's public registry record.
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department · +33 1 55 72 60 00 · scientificinformation@servier.com
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| Arizona Clinical Trials | Chandler, Arizona, United States | Recruiting |
| Orlando Clinical Research Center | Orlando, Florida, United States | Recruiting |
| American Research Corporation | San Antonio, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07250633