Clinical Pharmacology Study of EPI-589

JRCT ID: jRCT2071210022

Registered date:12/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Amyotrophic lateral sclerosis
• Date of first enrollment: 03/07/2018
• Target sample size: 68
• Study type: Interventional

Intervention(s)

Part A : Single oral administration (EPI-589 250, 500, 1000 mg/day or placebo)
Part B : Single oral administration (EPI-589 500 mg/day or placebo)
Part C : Multiple oral administration (EPI-589 1000, 1500 mg/day or placebo)
Part D : Single oral administration (EPI-589 500 mg/day)

Outcome(s)

Primary Outcome

Pharmacokinetic endpoints : Pharmacokinetic parameters
Safety endpoints : Adverse events, adverse drug reactions, Laboratory tests, Vital signs, 12-lead electrocardiogram (ECG)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 55age old
• Gender: Male

Include criteria

1) Healthy male Japanese or Caucasian subjects between 20 and 55 years of age (inclusive) at the time of consent.
2) Subject who was fully informed and understood the objectives, procedures, anticipated drug effects/pharmacological action and risks of the study and who voluntarily provided written consent to participate in the study.
3) Subject's body weight was between 50.0 and 80.0 kg (Japanese) and 50.0 and 100.0 kg (Caucasian), and body mass index (BMI) was at least 16 kg/m2 but no more than 32 kg/m2 at Screening.
4) Subject who was able to comply with the study requirements, including physical examination, assessments, and reporting symptoms.
5) Subject with female partners of childbearing potential practiced abstinence, consistent with lifestyle or acceptable birth control from the time of signing informed consent until at least 30 days after the last study drug administration.
6) Subject possessed an educational level and degree of understanding of English or Japanese that enabled him to communicate suitably with the Investigators and study coordinator.

Exclude criteria

1) Subject with a history of cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematological, respiratory, psychiatric, or neurologic disease, and who were considered ineligible for the study by the Investigator.
2) Subject with a clinically significant abnormal 12-lead ECG that may have jeopardized the subject's ability to complete the study or a Screening 12-lead ECG that demonstrated any 1 of the following: heart rate > 100 beats per minute, QT interval corrected for heart rate using Fridericia correction > 450 msec.
3) Subject who had a history of drug allergy.
4) Subject with any allergy or hypersensitivity to Coenzyme Q10 or Vitamin E supplements.
5) Subject with a history of substance abuse including alcohol and drugs, or a positive urine drug test at Screening.
6) Subject who had a positive immunology at Screening [Hepatitis B surface antigen, Hepatitis C virus antibody, syphilis serological testing, human immunodeficiency virus antibody/antigen].
7) Subject with any clinically significant abnormal physical examination, clinical laboratory values, vital signs, and 12-lead ECG findings at Screening.
8) Subject who was abusing or suspected to be abusing alcohol.
9) Subject who ordinarily consumed large quantities of caffeinated beverages (coffee, tea, green tea, cola, tonic drink, etc).
10) Subject with a history of tobacco dependency or subject who smoked a mean of more than 20 cigarettes daily.
11) Subject who previously received EPI-589.
12) Subject who had participated in an investigational drug study and received any investigational drug within 90 days prior to Screening, or who was participating in another clinical study during the conduct of this study.
13) Subject who had experienced significant blood loss or donated blood (> 400 mL) within 90 days or donated 200 mL of blood or more within 30 days prior to the initial study drug administration (Day 1). Subject who had donated blood components within 14 days prior to the initial study drug administration (Day 1) or intended to donate blood components or blood within 30 days after the last study visit.
14) Subject with a history of hospitalization (except for hospitalization for tests) within 45 days prior to Screening.
15) Subject with a disorder or history of a condition (such as malabsorption and gastrointestinal surgery) that may have interfered with drug absorption, distribution, metabolism, or excretion, or a clinically significant abnormality of the hepatic or renal system.
16) Subject who had consumed coenzyme Q10 or Vitamin E supplements within 14 days prior to the initial study drug administration (Day 1).
17) Subject who had consumed St. John's wort-containing foods or beverages within 14 days prior to the initial study drug administration (Day 1).
18) Subject who had consumed grapefruit or grapefruit-containing juices within 7 days prior to the initial study drug administration (Day 1).
19) Subject who had used prescription or over-the-counter medications within 14 days prior to the initial study drug administration (Day 1).
20) Subject who had consumed alcohol on the day before Screening or thereafter and 2 days before the initial study drug administration (Day 1) and thereafter.
21) Subject who was in the opinion of the Investigators unsuitable in any other way to participate in this study.

Related Information

• Primary Sponsor: Hamatani Tatsuto