drugset / 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
Phase 1
Completed
64 enrolled
Servier Bio-Innovation LLC
Institut de Recherches Internationales Servier · collab
RandomizedCrossoverOpen-labelOther
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)
Timeline
- Start
- 2023-04-14
- Primary completion
- 2023-07-28
- Completion
- 2023-07-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ciprofloxacin | Small molecule | 500 mg | Oral |
| Subject | Vorasidenib | Small molecule | 20 mg | Oral |
| Subject | Vorasidenib | Small molecule | 40 mg | Oral |
Indications
No indication recorded.