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Completed
NCT07824193
Drug-drug Interaction Study of Clemizole (EPX-100) in Healthy Participants
Conditions: Drug Drug Interaction
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 54
Sponsor: Epygenix
Location: Celerion Tempe Arizona
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07824193). StuddyBuddy aggregates publicly available trial information.