Healthy Participants
Conditions
Keywords
Multiple Ascending Dose, Single Ascending Dose
Brief summary
A study to evaluate the safety and tolerability of single and multiple ascending doses of EPX-100 in healthy adult participants.
Detailed description
This is a two-part study. Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of EPX-100 following single ascending doses (SAD). Part 2 is a randomized, double-blind, placebo- and positive-controlled (active comparator) study to evaluate the safety, tolerability, and PK of EPX-100 following multiple ascending doses (MAD). In addition, cardiac liability will be evaluated in each cohort.
Interventions
DRUGEPX-100
Oral solution
DRUGEPX-100-Matching Placebo
Oral Solution
DRUGMoxifloxacin
Over-encapsulated tablet
Capsule
Sponsors
Epygenix
Harmony Biosciences Management, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the concentration-time curve (AUC), From Time 0 to The Last Observed Nonzero Concentration (AUC0-last) of EPX-100 and Metabolites in Plasma | Part 1 SAD: up to Day 4, Part 2 MAD: up to Day 17 |
| AUC0-last of EPX-100 and Metabolites in Urine | Part 1 SAD: up to Day 4 |
| Maximum Observed Concentration (Cmax) of EPX-100 and Metabolites in Plasma | Part 1 SAD: up to Day 4, Part 2 MAD: up to Day 17 |
| Cmax of EPX-100 and Metabolites in Urine | Part 1 SAD: up to Day 4 |
| Change from Baseline in Electrocardiogram (ECG) QT Interval Corrected According to the Method of Fridericia (QTcF) | Part 2 MAD: Baseline and up to Day 16 |
Countries
United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORRobert Faulkner, PhD
Epygenix Therapeutics, Inc.
Outcome results
None listed