Overview

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

Status:
Recruiting

Trial end date:
2023-09-06

Target enrollment:

Participant gender:

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)

Phase:

Phase 1

Details

Lead Sponsor:

Servier Bio-Innovation LLC

Collaborator:

Institut de Recherches Internationales Servier

Treatments:

Ciprofloxacin