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Completed

NCT Number: NCT07824193

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

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.

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Key information

Conditions

Drug Drug Interaction

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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/exclusion criteria may apply, per protocol

Treatment and study plan

EPX-100

Drug

Oral solution

Other names: Clemizole hydrochloride

Itraconazole

Drug

Oral solution

Phenytoin

Drug

Phenytoin sodium extended-release capsules

Omeprazole

Drug

Delayed-release capsule

midazolam

Drug

Midazolam hydrochloride (HCl) syrup

bupropion

Drug

Bupropion HCl tablets

Primary outcomes

  1. Area Under The Concentration-time Curve (AUC), from Time 0 to the Last Observed Non-zero Concentration (AUC0-t) Of EPX-100

    Time frame: Up to Day 15

  2. AUC From Time 0 extrapolated to infinity (AUC0-inf) of EPX-100

    Time frame: Up to Day 15

  3. Maximum Observed Concentration (Cmax) of EPX-100

    Time frame: Up to Day 15

  4. AUC0-t of Omeprazole

    Time frame: Up to Day 15

  5. AUC0-inf of Omeprazole

    Time frame: Up to Day 15

  6. Cmax of Omeprazole

    Time frame: Up to Day 15

  7. AUC0-t of Midazolam

    Time frame: Up to Day 15

  8. AUC0-inf of Midazolam

    Time frame: Up to Day 15

  9. Cmax of Midazolam

    Time frame: Up to Day 15

  10. AUC0-t of Bupropion

    Time frame: Up to Day 19

  11. AUC0-inf of Bupropion

    Time frame: Up to Day 19

  12. Cmax of Bupropion

    Time frame: Up to Day 19

Secondary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events

    Time frame: Up to 12 Weeks

Sponsors and collaborators

Lead sponsor

Epygenix

Industry

Collaborators

  • Harmony Biosciences Management, Inc.

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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