EPX-100 first-in-human dose study in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-part Phase 1 trial in healthy volunteers. Part 1 uses randomized, double-blind, placebo-controlled SAD cohorts to assess safety, tolerability, and how the body processes EPX-100. Part 2 uses randomized, double-blind design with placebo and an active comparator to evaluate MAD safety, tolerability, pharmacokinetics, and cardiac safety across dose groups. Cardiac monitoring is included in each cohort. The study compares EPX-100 to matching placebo and includes an active reference to contextualize safety signals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Continuous nonsmoker who has not used nicotine- or tobacco-containing products for at least 3 months prior to (first) dosing.
* Body mass index ≥18.0 and ≤32.0 kilograms per square meter(kg/m\^2) at the Screening visit (defined as within 28 days prior to dosing).
* Medically healthy with no clinically significant medical history, physical examination findings, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs), as deemed by the Principal Investigator (PI) or designee.
* Part 2 only: No clinically significant history and presence of ECG findings as judged by the PI or designee at the Screening visit and at Check-In.

Exclusion Criteria:

* History of cholecystectomy.
* Has a family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member.
* History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
* History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions that the PI or designee considers to be clinically significant.
* History of presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome or sudden unexpected cardiac death at a young age).
* Part 2 only: history or presence of sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Where it's running

• Celerion
  Tempe, Arizona, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@harmonybiosciences.com
• Phone: see email

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.