clinical trial · NCT05843708
A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects
Servier Bio-Innovation LLC·phase1·completed·n = 64
Healthy SubjectsVorasidenib 40 mg Oral TabletCiprofloxacin 500 mg Oral TabletVorasidenib 10 mg Oral Tablet
brief summary
The objectives of this study are: * To evaluate the effect of a low-fat meal on the pharmacokinetics (PK) of vorasidenib following a single oral dose of 40 mg vorasidenib in healthy adult subjects (substudy A) * To evaluate the effect of multiple-dose ciprofloxacin (strong cytochrome P450 \[CYP\]1A2 inhibitor) on the single-dose PK of vorasidenib in healthy adult subjects (substudy B)
started
Apr 14, 2023
primary completion
Jul 28, 2023
completion
Jul 28, 2023
last updated
Feb 14, 2025
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol