Clinical Trials in the USA / NCT07879170
Recruiting
Phase 1
A Single and Multiple Ascending Dose Study of EPX-100 in Healthy Adult Participants
NCT07879170 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Healthy Participants
Investigational drug(s) / intervention(s)
EPX-100: Oral solution
EPX-100-Matching Placebo: Oral Solution
Moxifloxacin: Over-encapsulated tablet
Moxifloxacin-Matching Placebo: Capsule
Study summary
A study to evaluate the safety and tolerability of single and multiple ascending doses of EPX-100 in healthy adult participants.
Eligibility
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.
Primary outcome measure(s)
- Number of Participants with Treatment Emergent Adverse Events (TEAEs) in Part 1 SAD — Part 1 SAD: up to Day 18
- Number of Participants with TEAEs in Part 2 MAD — Part 2 MAD: up to Day 31
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Celerion | Tempe | Arizona | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07879170 on ClinicalTrials.gov ↗ ← All trials in the USA