Drug-drug Interaction Study of Clemizole (EPX-100) in Healthy Participants
Public ClinicalTrials.gov record NCT07824193. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07824193
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 54 participants
Conditions and interventions
Conditions
Interventions
- EPX-100 Drug
- Itraconazole Drug
- Phenytoin Drug
- Omeprazole Drug
- Midazolam Drug
- Bupropion Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 14, 2025
- Primary completion
- Apr 2, 2025
- Completion
- Apr 2, 2025
- Last update posted
- Sep 16, 2026
2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07824193, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 16, 2026 · Synced Sep 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07824193 live on ClinicalTrials.gov.