A Phase 1 interventional study of EPX-100 and Itraconazole in Drug Drug Interaction, sponsored by Epygenix. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Epygenix · Phase 1, Interventional, and Basic science
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.
Epygenix is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Note: Additional inclusion/exclusion criteria may apply, per protocol
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Oral solution
Also known as: Clemizole hydrochloride
Oral solution
Phenytoin sodium extended-release capsules
Delayed-release capsule
Midazolam hydrochloride (HCl) syrup
Bupropion HCl tablets
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
Number of Participants with Treatment Emergent Adverse Events
Time frame: Up to 12 Weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2025 to primary completion in Apr 2025, 2 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clemizole hydrochloride
Epygenix