Drug Drug InteractionPhase 1NCT07824193
Drug-drug Interaction Study of Clemizole (EPX-100) in Healthy Participants
A Phase 1 study testing EPX-100, Itraconazole and Phenytoin in people with Drug Drug Interaction, run by Epygenix at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction
- What is being tested?
- EPX-100, Itraconazole and Phenytoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 3 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- EPX-100, Itraconazole, Phenytoin, Omeprazole, Midazolam
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPX-100Drug
Also called Clemizole hydrochloride
Oral solution
ItraconazoleDrug
Oral solution
PhenytoinDrug
Phenytoin sodium extended-release capsules
OmeprazoleDrug
Delayed-release capsule
MidazolamDrug
Midazolam hydrochloride (HCl) syrup
BupropionDrug
Bupropion HCl tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: EPX-100; Drug: Omeprazole; Drug: Midazolam; Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under The Concentration-time Curve (AUC), from Time 0 to the Last Observed Non-zero Concentration (AUC0-t) Of EPX-100
Measured: Up to Day 15
AUC From Time 0 extrapolated to infinity (AUC0-inf) of EPX-100
Measured: Up to Day 15
Maximum Observed Concentration (Cmax) of EPX-100
Measured: Up to Day 15
AUC0-t of Omeprazole
Measured: Up to Day 15
AUC0-inf of Omeprazole
Measured: Up to Day 15
Cmax of Omeprazole
Measured: Up to Day 15
AUC0-t of Midazolam
Measured: Up to Day 15
AUC0-inf of Midazolam
Measured: Up to Day 15
Cmax of Midazolam
Measured: Up to Day 15
AUC0-t of Bupropion
Measured: Up to Day 19
AUC0-inf of Bupropion
Measured: Up to Day 19
Cmax of Bupropion
Measured: Up to Day 19
Secondary outcomes (1)
Number of Participants with Treatment Emergent Adverse Events
Measured: Up to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start15 Jan 2025
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epygenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harmony Biosciences Management, Inc.
- Responsible party
- Sponsor
- Investigators
- Amit Ray, MD, MBA, FAES, FAAN, Study director, Epygenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824193
- Sponsor's protocol ID
- EPX-100-CL-101
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07824193
- Acronym / sponsor ID
- EPX-100-CL-101
- Conditions
- Drug Drug Interaction
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- EpygenixIndustry (pharma, biotech, devices)
- Collaborators
- Harmony Biosciences Management, Inc.
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Itraconazole | Experimental | Drug: EPX-100, Drug: ItraconazoleTreatment 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. |
| Part 2 - Phenytoin | Experimental | Drug: EPX-100, Drug: PhenytoinTreatment 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. |
| Part 3 - Omeprazole, Midazolam, and Bupropion | Experimental | Drug: EPX-100, Drug: Omeprazole, Drug: Midazolam, Drug: BupropionTreatment 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPX-100Also: Clemizole hydrochlorideOral solution | Drug | Part 1 - Itraconazole, Part 2 - Phenytoin, Part 3 - Omeprazole, Midazolam, and Bupropion |
| ItraconazoleOral solution | Drug | Part 1 - Itraconazole |
| PhenytoinPhenytoin sodium extended-release capsules | Drug | Part 2 - Phenytoin |
| OmeprazoleDelayed-release capsule | Drug | Part 3 - Omeprazole, Midazolam, and Bupropion |
| MidazolamMidazolam hydrochloride (HCl) syrup | Drug | Part 3 - Omeprazole, Midazolam, and Bupropion |
| BupropionBupropion HCl tablets | Drug | Part 3 - Omeprazole, Midazolam, and Bupropion |
Primary outcome
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
AUC From Time 0 extrapolated to infinity (AUC0-inf) of EPX-100
Time frame: Up to Day 15
Maximum Observed Concentration (Cmax) of EPX-100
Time frame: Up to Day 15
AUC0-t of Omeprazole
Time frame: Up to Day 15
AUC0-inf of Omeprazole
Time frame: Up to Day 15
Cmax of Omeprazole
Time frame: Up to Day 15
AUC0-t of Midazolam
Time frame: Up to Day 15
AUC0-inf of Midazolam
Time frame: Up to Day 15
Cmax of Midazolam
Time frame: Up to Day 15
AUC0-t of Bupropion
Time frame: Up to Day 19
AUC0-inf of Bupropion
Time frame: Up to Day 19
Cmax of Bupropion
Time frame: Up to Day 19
1 secondary outcome
Number of Participants with Treatment Emergent Adverse Events
Time frame: Up to 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Ray, MD, MBA, FAES, FAAN study director
Epygenix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EPX-100, Itraconazole and Phenytoin in people with Drug Drug Interaction, run by Epygenix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.