Clinical trial
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
NCT05674474 is registered in ClinicalTrials.gov with Institut de Recherches Internationales Servier as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- 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
- Lead sponsor
- Institut de Recherches Internationales Servier
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- March 14, 2023
- Completion date
- July 18, 2023
- Enrollment
- 16 (actual)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.
hepatic impairment