NCT04069689

Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects.

A Phase I, Placebo-Controlled, Double-Blind, 2-Period Study to Assess Safety and Pharmacokinetics of Escalating Single and Multiple Oral Doses of EPX-100 in Fasting Healthy Subjects and Following a High-Fat Meal

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Epygenix · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a placebo-controlled, double-blind, 2-period study in 3 sequential groups of 8 healthy subjects each. The safety and pharmacokinetics of escalating single and multiple oral doses of EPX-100 will be assessed in fasting healthy subjects and following a high-fat meal.

Detailed description

This is a placebo-controlled, double-blind, 2-period study in 3 sequential groups of 8 healthy subjects each. Subjects will be admitted on two occasions to the clinical research center: Day -1 for 14 days and discharged on Day 13 and then re-admitted on Day 19 for 3 days and discharged on Day 21. Subjects will fast after midnight on the day of each admission. On Day 1 of study of the low-dose group (cohort 1), subjects will be randomized to a single dose of 20 mg EPX-100 (N=6) or placebo (N=2) in the morning and then remain fasting for 4 hours after dosing. Safety will be assessed and blood samples will be obtained to calculate PK at the following time points: 0, 0.5, 1, 2, 4, 6, 8, 12, 18, and 24 hours following the first dose of EPX-100 or placebo. The subjects will remain in the study research center for daily 8 AM (± 2 hours) blood samples for 5 consecutive days (Days 3 - 7; one blood sample per day). On Days 8 - 11, subjects will be administered 20 mg EPX-100 or placebo twice daily (BID) at least one hour prior to the morning meal and at least 2 hours after the evening meal (approximately 12 hours apart). A single dose of 20 mg EPX-100 or placebo will be administered on Day 12 in the fasting state and subjects will remain fasting for 4 hours after dosing. Blood samples will be drawn at the following time points: 0, 0.5, 1, 2, 4, 6, 8, 12, 18, and 24 hours to determine multiple-dose PK. After a washout period of at least one week following the last dose of EPX-100 or placebo, subjects will return to the clinical research center on Day 19 and safety will be assessed. On Day 20, subjects will ingest a high-fat morning meal over 30 minutes; thereafter, the subject will receive a single dose of 20 mg EPX- 100 or placebo at 30 minutes after the start of the meal. Blood samples will be drawn at the following time points: 0, 0.5, 1, 2, 4, 6, 8, 12, 18, and 24 hours after the administration of study drug to determine the PK of EPX-100 in the fed state. Once the 20 mg dose level of EPX-100 is evaluated and the Safety Review Committee (SRC) determines it is safe to escalate to the next dose level, subsequent groups of 8 subjects each will be administered 40 mg (cohort 2) and 80 mg (cohort 3) (N=6 active drug, N=2 matching placebo) EPX-100 and follow the same study procedures as the low-dose group (cohort 1). Throughout the study period, subjects will undergo cardiac assessments, safety assessments, and PK sampling.

Conditions

• Dravet Syndrome

Interventions

Type	Name	Description
DRUG	EPX-100 (Clemizole Hydrochloride)	EPX-100 (Clemizole Hydrochloride)
DRUG	Placebos	Placebo to match EPX-100

Timeline

• Start date: 2019-08-29
• Primary completion: 2019-11-27
• Completion: 2019-11-27
• First posted: 2019-08-28
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study