drugset / Trial / NCT06965881
Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamazepine or Itraconazole With Radiprodil in Healthy Adults
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 1, open-label, 2-part study to evaluate the effect of multiple doses of oral carbamazepine or oral itraconazole on the plasma pharmacokinetic profile of radiprodil in healthy adult participants. In addition, the safety and tolerability of radiprodil given together with oral carbamazepine or itraconazole will be assessed.
Timeline
- Start
- 2025-05-08
- Primary completion
- 2025-07-08
- Completion
- 2025-07-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carbamazepine | Small molecule | 100 mg | Oral |
| Subject | Carbamazepine | Small molecule | 300 mg | Oral |
| Subject | Itraconazole | Small molecule | 200 mg | Oral |
| Subject | Radiprodil | Small molecule | 7.5 mg | Oral |
| Subject | Radiprodil | Small molecule | 15 mg | Oral |
| Subject | Radiprodil | Small molecule | 30 mg | Oral |