A Single and Multiple Ascending Dose Study of EPX-100 in Healthy Adult Participants
Epygenix · with Harmony Biosciences Management, Inc. · NCT07879170
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–55 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1
- Target enrollment
- 88
- US sites recruiting
- 1
- Study start
- August 5, 2026
- Record last updated
- October 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
A study to evaluate the safety and tolerability of single and multiple ascending doses of EPX-100 in healthy adult participants.
Being studied: EPX-100; EPX-100-Matching Placebo; Moxifloxacin; Moxifloxacin-Matching Placebo
Conditions: Healthy Participants
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
Celerion
Tempe, AZ 85283
Study contacts (from the official record)
- Clinical Trials Administrator · see email · clinicaltrials@harmonybiosciences.com
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