drugset / Trial / NCT07824193
Drug-drug Interaction Study of Clemizole (EPX-100) in Healthy Participants
Non-randomizedParallel-groupOpen-labelBasic science
Summary
This is a 3-part, drug-drug interaction study in healthy participants. Each part is designed as a 2-period, fixed-sequence and can be conducted concurrently. Part 1 will assess the effect of itraconazole on the pharmacokinetics (PK) of EPX-100. Part 2 will assess the effect of phenytoin on the PK of EPX-100. Part 3 will assess the effect of EPX-100 on the PK of omeprazole, midazolam, and bupropion.
Timeline
- Start
- 2025-01-15
- Primary completion
- 2025-04-03
- Completion
- 2025-04-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupropion | Small molecule | — | — |
| Subject | Clemizole | Small molecule | — | Oral |
| Subject | Itraconazole | Small molecule | — | Oral |
| Subject | Midazolam | Small molecule | — | — |
| Subject | Omeprazole | Other / unclassified | — | — |
| Subject | Phenytoin | Unknown | — | — |
Indications
No indication recorded.