drugset / Trial / NCT06975605
Phase 1, Open-label, Drug-drug Interaction Study to Assess Effect Between Radiprodil and the Co-administered Drugs.
NaSequentialOpen-labelTreatment
Summary
This is a Phase 1, open-label, 3-period study to determine radiprodil's potential to act as a perpetrator of cytochrome P-450 (CYP) metabolic pathways and transporter pathways. The study will evaluate the pharmacokinetics (PK) and safety effects of co-administration of radiprodil with oral midazolam, rosuvastatin, warfarin, digoxin, and omeprazole in healthy adult subjects. The study will be conducted in 1 cohort of healthy adult participants only.
Timeline
- Start
- 2025-05-20
- Primary completion
- 2025-07-10
- Completion
- 2025-07-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Digoxin | Other / unclassified | 0.25 mg | — |
| Subject | Midazolam | Small molecule | 1 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 20 mg | — |
| Subject | Radiprodil | Small molecule | 7.5 mg | — |
| Subject | Radiprodil | Small molecule | 15 mg | — |
| Subject | Radiprodil | Small molecule | 30 mg | — |
| Subject | Rosuvastatin | Small molecule | 10 mg | — |
| Subject | Warfarin | Small molecule | 10 mg | — |
| Background | Vitamin K | Unknown | 10 mg | — |