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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04069689
• Date of registration: 22/08/2019
• Prospective Registration: Yes
• Primary sponsor: Epygenix
• Public title: Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects.
• Scientific 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
• Date of first enrolment: August 29, 2019
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04069689
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Hahn-Jun Lee, Ph.D.
• Affiliation: Epygenix Therapeutics, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Signed informed consent prior to any study-related procedures

2. Male or female subjects 18 to 50 years of age inclusive

3. Subject's body mass index (BMI) is = 30 kg/m2

4. Female subjects of childbearing potential must not be pregnant or lactating with a
negative serum human chorionic gonadotropin (HCG) pregnancy test result at Screening,
Day -1, or Day 19.

5. Female subjects of childbearing potential and male subjects must use an adequate
method of contraception from Screening until completion of the study. Acceptable
methods of contraception are barrier methods (male condom, female condom, diaphragm,
cervical cap, spermicide, or intrauterine device [IUD]), surgical sterility
(documented doctor's report of vasectomy, hysterectomy, and/or bilateral
oophorectomy), oral hormonal contraceptives, hormonal IUD, and/or postmenopausal
status (defined as at least 1 year without menses as demonstrated by medical history
or subject report).

6. Subject is in good health as determined by vital signs, medical history, physical
exam, and safety laboratory analyses at Screening and during the study.

Exclusion Criteria:

1. Subject has used an investigational product within 30 days prior to enrollment or
during the study.

2. Subject has used prescription or non-prescription drugs (including vitamins, minerals,
and herbal/plant-derived preparations) within 2 weeks of enrollment (excluding oral
hormonal contraceptives, hormonal IUD, hormone replacement therapy, and acetaminophen)
unless deemed acceptable by the Investigator in consultation with the Sponsor.

3. Subject has a positive drug and/or alcohol test at Screening, Day -1, or Day 19.

4. Subject has a history of drug or alcohol abuse within 2 years before Screening.

5. Subject is unable to abstain from ingesting alcohol, caffeine, grapefruit or
grapefruit juice, pomelo or pomelo juice, or Seville oranges or Seville orange juice
for 72 hours prior to dosing and throughout the dosing periods.

6. Concurrent use of substances, including drugs, known to interfere with EPX-100,
including moderate or severe inducers or inhibitors of CYP3A4 and CYP2D6.

7. The subject has a clinically significant history of endocrinologic, hematologic,
hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic,
psychiatric, renal, and/or other major diseases or malignancy.

8. Subject has evidence of any of the following cardiac conduction abnormalities:

1. QTcF interval >430 msec for males and >450 msec for females

2. PR interval ? 200 msec

3. Evidence of second- or third-degree atrioventricular block (AVB)

4. Electrocardiographic evidence of complete left bundle branch block (LBBB),
complete right bundle branch block (RBBB), or incomplete LBBB

5. Intraventricular conduction delay with QRS duration >120 msec

6. Heart rate <40 bpm

7. Pathological Q waves (defined as >40 msec or depth >0.4-0.5 mV)

8. Evidence of ventricular pre-excitation.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dravet Syndrome

Intervention(s)

Drug: EPX-100 (Clemizole Hydrochloride)

Drug: Placebos

Primary Outcome(s)

Treatment-emergent adverse events (TEAEs) [Time Frame: 21 days]

Serial ECGs - QTcF Interval [Time Frame: 21 days]

Physical Examinations Including Actual Body Weight [Time Frame: 21 days]

Secondary Outcome(s)

Plasma Concentrations of EPX-100 in Fasting State [Time Frame: 13 days]

Plasma Concentration of EPX-100 following a High-Fat Meal [Time Frame: 24 hours]

Secondary ID(s)

EPX-100-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors