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

NCT07824193 | Completed Phase 1 FDA Drug

• 1 other identifier: EPX-100-CL-101
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Drug Interaction

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events

  Up to 12 Weeks

Study Arms (3)

Part 1 - Itraconazole

EXPERIMENTAL

Treatment A (Period 1): EPX-100 on Day 1. Treatment B (Period 2): itraconazole twice daily (BID) on Day 1; then once daily (QD) on Days 2-5, with EPX-100 administered approximately 2 hours after itraconazole dosing on Day 5.

Drug: EPX-100; Drug: Itraconazole

Part 2 - Phenytoin

EXPERIMENTAL

Treatment C (Period 1): EPX-100 on Day 1. Treatment D (Period 2): phenytoin three times daily (TID) on Days 1 to Day 14, with EPX-100 coadministered on the morning of Day 14.

Drug: EPX-100; Drug: Phenytoin

Part 3 - Omeprazole, Midazolam, and Bupropion

EXPERIMENTAL

Treatment E (Period 1): omeprazole on Day 1; midazolam on Day 2; bupropion on Day 3. Treatment F (Period 2): EPX-100 BID on Days 1-18 with omeprazole coadministered on the morning of Day 12; midazolam coadministered on the morning of Day 14; bupropion coadministered on the morning of Day 15.

Drug: EPX-100; Drug: Omeprazole; Drug: Midazolam; Drug: Bupropion

Interventions

EPX-100 DRUG

Oral solution

Also known as: Clemizole hydrochloride

Part 1 - Itraconazole; Part 2 - Phenytoin; Part 3 - Omeprazole, Midazolam, and Bupropion

Itraconazole DRUG

Oral solution

Part 1 - Itraconazole

Phenytoin DRUG

Phenytoin sodium extended-release capsules

Part 2 - Phenytoin

Omeprazole DRUG

Delayed-release capsule

Part 3 - Omeprazole, Midazolam, and Bupropion

Midazolam DRUG

Midazolam hydrochloride (HCl) syrup

Part 3 - Omeprazole, Midazolam, and Bupropion

Bupropion DRUG

Bupropion HCl tablets

Part 3 - Omeprazole, Midazolam, and Bupropion

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Epygenix: lead
• Harmony Biosciences Management, Inc.: collaborator

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

Itraconazole; Phenytoin; Omeprazole; Midazolam; Bupropion

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Hydantoins; Imidazolidines; Imidazoles; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines; Propiophenones; Ketones

Study Officials

• Amit Ray, MD, MBA, FAES, FAAN

  Epygenix

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: January 15, 2025
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)