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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07824193

Enrollment

Registered

2026-09-17

Start date

2025-01-15

Completion date

2025-04-03

Last updated

2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Drug Interaction

Keywords

Healthy Volunteers

Brief 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.

Interventions

DRUGEPX-100

Oral solution

DRUGItraconazole

Oral solution

DRUGPhenytoin

Phenytoin sodium extended-release capsules

DRUGOmeprazole

Delayed-release capsule

DRUGMidazolam

Midazolam hydrochloride (HCl) syrup

DRUGBupropion

Bupropion HCl tablets

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing. * Body mass index ≥18.0 and ≤32.0 kilograms per square meter(kg/m\^2) within 28 days prior to first dosing.

Exclusion criteria

* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. * History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee. * History of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study. Note: Additional inclusion/

Design outcomes

Primary

Measure	Time frame
Area Under The Concentration-time Curve (AUC), from Time 0 to the Last Observed Non-zero Concentration (AUC0-t) Of EPX-100	Up to Day 15
AUC From Time 0 extrapolated to infinity (AUC0-inf) of EPX-100	Up to Day 15
Maximum Observed Concentration (Cmax) of EPX-100	Up to Day 15
AUC0-t of Omeprazole	Up to Day 15
AUC0-inf of Omeprazole	Up to Day 15
Cmax of Omeprazole	Up to Day 15
AUC0-t of Midazolam	Up to Day 15
AUC0-inf of Midazolam	Up to Day 15
Cmax of Midazolam	Up to Day 15
AUC0-t of Bupropion	Up to Day 19
AUC0-inf of Bupropion	Up to Day 19
Cmax of Bupropion	Up to Day 19

Secondary

Measure	Time frame
Number of Participants with Treatment Emergent Adverse Events	Up to 12 Weeks

Countries

United States

Contacts

STUDY_DIRECTORAmit Ray, MD, MBA, FAES, FAAN

Epygenix

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026