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COMPLETED
NCT07824193
PHASE1

Drug-drug Interaction Study of Clemizole (EPX-100) in Healthy Participants

Sponsor: Epygenix

View on ClinicalTrials.gov

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

Interventions

DRUG

EPX-100

Oral solution

DRUG

Itraconazole

Oral solution

DRUG

Phenytoin

Phenytoin sodium extended-release capsules

DRUG

Omeprazole

Delayed-release capsule

DRUG

Midazolam

Midazolam hydrochloride (HCl) syrup

DRUG

Bupropion

Bupropion HCl tablets

Locations (1)

Celerion

Tempe, Arizona, United States