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History of Changes for Study: NCT04069689
Phase I Study to Assess Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects.
Latest version (submitted June 23, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 23, 2019 None (earliest Version on record)
2 August 26, 2019 Outcome Measures, Study Identification and Study Status
3 September 18, 2019 Study Status, Outcome Measures, Eligibility, Conditions and Study Description
4 February 14, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 June 23, 2020 Study Status
Comparison Format:

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Study NCT04069689
Submitted Date:  August 23, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: EPX-100-002
Brief Title: Phase I Study to Assess Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects.
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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2019
Overall Status: Recruiting
Study Start: August 29, 2019
Primary Completion: November 27, 2019 [Anticipated]
Study Completion: November 27, 2019 [Anticipated]
First Submitted: August 22, 2019
First Submitted that
Met QC Criteria:
August 23, 2019
First Posted: August 28, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
August 23, 2019
Last Update Posted: August 28, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Epygenix
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:

This is a placebo-controlled, double-blind, 2-period study in 3 sequential groups of 8 healthy subjects each. Subjects will remain at the clinical research center for the first 8 days of the study. Subjects will fast after midnight on day of 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 and metabolite (M6) or placebo.

On Days 2-5, 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 6 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 one week following the last blood draw, subjects will return to the clinical research center on Day 14 and safety will be assessed. On Day 15, 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 and metabolite M6 in the fed state.

Once the 20 mg dose level of EPX-100 is evaluated and the investigator/sponsor 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 (Days 1-2, 6-7, and 15-16).

Open or close this module Conditions
Conditions: Dravet Syndrome
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 24 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: EPX-100
Single and multiple doses of 20, 40, 80mg of EPX-100 (Clemizole Hydrochloride)
Drug: EPX-100 (Clemizole Hydrochloride)
EPX-100 (Clemizole Hydrochloride)
Other Names:
  • Clemizole Hydrochloride
  • Clemizole HCL
Placebo Comparator: Placebo
Single and multiple doses of 20, 40, 80mg of placebo
Drug: Placebos
Placebo to match EPX-100
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Treatment-emergent adverse events (TEAEs)
[ Time Frame: 16 days ]

To evaluate the safety of single and multiple escalating doses of oral EPX-100 in healthy subjects.
2. Clinical Laboratory Tests - Urinalysis
[ Time Frame: 16 days ]

To evaluate the safety of single and multiple escalating doses of oral EPX-100 in healthy subjects.
3. Serial ECGs - QTcF Interval
[ Time Frame: 16 days ]

To evaluate the safety of single and multiple escalating doses of oral EPX-100 in healthy subjects.
4. Physical Examinations Including Actual Body Weight
[ Time Frame: 16 days ]

To evaluate the safety of single and multiple escalating doses of oral EPX-100 in healthy subjects.
5. Clinical Laboratory Tests - Hematology
[ Time Frame: 16 days ]

To evaluate the safety of single and multiple escalating doses of oral EPX-100 in healthy subjects.
6. Clinical Laboratory Tests - Chemistry Panel
[ Time Frame: 16 days ]

To evaluate the safety of single and multiple escalating doses of oral EPX-100 in healthy subjects.
Secondary Outcome Measures:
1. Plasma Concentrations of EPX-100 in Fasting State
[ Time Frame: 7 days ]

Determine the pharmacokinetic (PK) profile of single and multiples doses of 20 mg, 40 mg, and 80 mg twice daily of EPX-100.
2. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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 14.
  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 14.
  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.
Open or close this module Contacts/Locations
Central Contact Person: Hahn-Jun Lee, Ph.D.
Telephone: (201) 724-1786
Email: hahnjun7@epygenix.com
Central Contact Backup: Dave Luke, Pharm.D
Telephone: (860) 464-8402
Email: DLuke4@Comcast.net
Study Officials: Hahn-Jun Lee, Ph.D.
Study Director
Epygenix Therapeutics, Inc.
Locations: United States, New Jersey
TKL Research
[Recruiting]
Fair Lawn, New Jersey, United States, 07410
Contact:Contact: Irina Krause 201-587-0500 Ext. 2292
Contact:Principal Investigator: Jesson Yeh, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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