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

NCT04069689 | Completed Phase 1 FDA Drug

• 1 other identifier: EPX-100-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dravet Syndrome

Keywords

Clemizole

Outcome Measures

Primary Outcomes (3)

• Treatment-emergent adverse events (TEAEs)

  To evaluate the safety of single and multiple escalating doses of oral EPX-100 in healthy subjects.

  21 days

• Serial ECGs - QTcF Interval

  To evaluate the safety of single and multiple escalating doses of oral EPX-100 in healthy subjects.

  21 days

• Physical Examinations Including Actual Body Weight

  To evaluate the safety of single and multiple escalating doses of oral EPX-100 in healthy subjects.

  21 days

Secondary Outcomes (2)

• Plasma Concentrations of EPX-100 in Fasting State

  13 days

• Plasma Concentration of EPX-100 following a High-Fat Meal

  24 hours

Study Arms (2)

EPX-100

EXPERIMENTAL

Single and multiple doses of 20, 40, 80mg of EPX-100 (Clemizole Hydrochloride)

Drug: EPX-100 (Clemizole Hydrochloride)

Placebo

PLACEBO COMPARATOR

Single and multiple doses of 20, 40, 80mg of placebo

Drug: Placebos

Interventions

EPX-100 (Clemizole Hydrochloride) DRUG

EPX-100 (Clemizole Hydrochloride)

Also known as: Clemizole Hydrochloride, Clemizole HCL

EPX-100

Placebos DRUG

Placebo to match EPX-100

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent prior to any study-related procedures
• Male or female subjects 18 to 50 years of age inclusive
• Subject's body mass index (BMI) is ≤ 30 kg/m2
• 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.
• 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).
• Subject is in good health as determined by vital signs, medical history, physical exam, and safety laboratory analyses at Screening and during the study.

You may not qualify if:

• Subject has used an investigational product within 30 days prior to enrollment or during the study.
• 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.
• Subject has a positive drug and/or alcohol test at Screening, Day -1, or Day 19.
• Subject has a history of drug or alcohol abuse within 2 years before Screening.
• 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.
• Concurrent use of substances, including drugs, known to interfere with EPX-100, including moderate or severe inducers or inhibitors of CYP3A4 and CYP2D6.
• 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.
• Subject has evidence of any of the following cardiac conduction abnormalities:
• QTcF interval \>430 msec for males and \>450 msec for females
• PR interval ⩾ 200 msec
• Evidence of second- or third-degree atrioventricular block (AVB)
• Electrocardiographic evidence of complete left bundle branch block (LBBB), complete right bundle branch block (RBBB), or incomplete LBBB
• Intraventricular conduction delay with QRS duration \>120 msec
• Heart rate \<40 bpm
• Pathological Q waves (defined as \>40 msec or depth \>0.4-0.5 mV)

Sponsors & Collaborators

• Epygenix: lead

Study Sites (1)

TKL Research

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Conditions

Epilepsies, Myoclonic

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Officials

• Hahn-Jun Lee, Ph.D.

  Epygenix Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: August 29, 2019
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)