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Drug-drug Interaction Study of Clemizole (EPX-100) in Healthy Participants
Sponsor: Epygenix
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.
Official title: A Phase 1, 3-Part Study to Evaluate the Effect of CYP3A4 Inhibition and Induction on the Pharmacokinetics of Clemizole and the Effect of Clemizole on the Pharmacokinetics of CYP2C19, CYP3A4, and CYP2B6 Substrates in Healthy Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2025-01-15
Completion Date
2025-04-03
Last Updated
2026-09-17
Healthy Volunteers
Yes
Conditions
Interventions
EPX-100
Oral solution
Itraconazole
Oral solution
Phenytoin
Phenytoin sodium extended-release capsules
Omeprazole
Delayed-release capsule
Midazolam
Midazolam hydrochloride (HCl) syrup
Bupropion
Bupropion HCl tablets
Locations (1)
Celerion
Tempe, Arizona, United States