Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects.
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|ClinicalTrials.gov Identifier: NCT04069689|
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : June 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dravet Syndrome||Drug: EPX-100 (Clemizole Hydrochloride) Drug: Placebos||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||August 29, 2019|
|Actual Primary Completion Date :||November 27, 2019|
|Actual Study Completion Date :||November 27, 2019|
Single and multiple doses of 20, 40, 80mg of EPX-100 (Clemizole Hydrochloride)
Drug: EPX-100 (Clemizole Hydrochloride)
EPX-100 (Clemizole Hydrochloride)
Placebo Comparator: Placebo
Single and multiple doses of 20, 40, 80mg of placebo
Placebo to match EPX-100
- Treatment-emergent adverse events (TEAEs) [ Time Frame: 21 days ]To evaluate the safety of single and multiple escalating doses of oral EPX-100 in healthy subjects.
- Serial ECGs - QTcF Interval [ Time Frame: 21 days ]To evaluate the safety of single and multiple escalating doses of oral EPX-100 in healthy subjects.
- Physical Examinations Including Actual Body Weight [ Time Frame: 21 days ]To evaluate the safety of single and multiple escalating doses of oral EPX-100 in healthy subjects.
- Plasma Concentrations of EPX-100 in Fasting State [ Time Frame: 13 days ]Determine the pharmacokinetic (PK) profile of single and multiples doses of 20 mg, 40 mg, and 80 mg twice daily of EPX-100.
- Plasma Concentration of EPX-100 following a High-Fat Meal [ Time Frame: 24 hours ]Determine the PK profile of a single dose of EPX-100 in the fasting state compared with after a high-fat meal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069689
|United States, New Jersey|
|Fair Lawn, New Jersey, United States, 07410|
|Study Director:||Hahn-Jun Lee, Ph.D.||Epygenix Therapeutics, Inc.|