Formulation Pharmacokinetics Study of EPI-589

JRCT ID: jRCT2071220047

Registered date:27/08/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Amyotrophic lateral sclerosis
• Date of first enrollment: 31/08/2022
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Subjects receive a test formulation (containing 1000 mg of EPI-589) or a reference formulation (containing 1000 mg of EPI-589) once orally in period 1 and period 2.

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 subject between 20-55 years of age (inclusive) at the time of consent.
2)Subject who is fully informed and understands the objectives, procedures, anticipated drug effects/pharmacological action, and risks of the study and who voluntarily provides written consent to participate in the study.
3)Subject with a body weight of between 50.0 kg and 80.0 kg, and a body mass index of at least 16 but lower than 25 at screenin.
4)Subject who is able to comply with the study requirements, including all assessments, physical examination, and reporting of symptoms.
5)Subject with partners of childbearing potential must be practicing abstinence consistently in their lifestyle or be willing to use acceptable and effective birth control from the initial study drug administration until at least 30 days after the last study drug administration.
6)Subject must possess an educational level and degree of understanding of Japanese that enables them to communicate suitably with investigators and study staff.

Exclude criteria

1)Subject with a history of cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematological, respiratory, psychiatric, or neurologic disease, and who was considered ineligible for the study by the investigator.
2)Subject with an abnormal 12-lead ECG that may jeopardize the subject's safety if he/she participates in the study, or a screening 12-lead ECG that demonstrated any one of the following:
Heart rate > 100 bpm or < 50 bpm
QRS interval > 120 msec
QTcF > 450 msec
PR interval > 200 msec
3)Subject who has a history of drug allergy.
4)Subject with any allergy or hypersensitivity to Coenzyme Q10 or Vitamin E.
5)Subject who has a positive immunology at screening.
6)Subject who has a clinically significant abnormality in hematology test, blood chemistry (serum) test, urinalysis, coagulation panel, or lipid panel at screening.
7)Subject who has a history of excessive alcohol consumption (roughly defined as drinking at least 1.3 L of beer or 360 mL of sake daily).
8)Subject who ordinarily drinks large quantities (approximately 1.8 L daily or more) of caffeinated beverages (coffee, tea, green tea, cola, tonic drink, etc.).
9)Subject with a history of tobacco dependency or subject who smokes, on average, more than 20 cigarettes daily.
10)Subject who previously received EPI-589.
11)Subject who has participated in an investigational drug study and received any investigational drug within 90 days prior to screening visit, or who is currently participating in another clinical trial.
12)Subject with a history of hospitalization within 45 days prior to screening visit (unless due to tests).
13)Subject with a disorder or history of a condition that may interfere with drug absorption, distribution, metabolism, or excretion (including a subject with a clinically significant abnormality of the hepatic or renal system, a subject with malabsorption, or a subject with a history of gastrointestinal surgery that may impact drug absorption or metabolism).
14)Subject with a history of alcohol or drug abuse, or a positive urine drug test at screening or on Period 1 Day -1.
15)Subject who has a CK, myoglobin (serum and urine), AST, or ALT exceeding the ULN in blood chemistry (serum) test or urinalysis at screening, or who has a CK exceeding the ULN in blood chemistry (serum) test on Period 1 Day -1.
16)Subject who has 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. Subject who has donated blood components within 14 days prior to the initial study drug administration or intends to donate blood components or blood within 30 days after follow-up.
17)Subject who has used prescription or over-the-counter medications (including herbal supplements) within 14 days prior to the initial study drug administration.
18)Subject who consumed Coenzyme Q10 or Vitamin E drugs or supplements within 14 days prior to the initial study drug administration.
19)Subject who consumed St. John's wort-containing foods or beverages within 14 days prior to the initial study drug administration.
20)Subject who consumed any foods or beverages containing grapefruit or Seville orange within 7 days prior to the initial study drug administration.
21)Subject who has consumed alcohol between the day before and the time of screening test or on Period 1 Day -2 and thereafter.
22)Subject who responds Yes to Item 4 or 5 of Suicidal ideation on the Columbia Suicide Severity Rating Scale on Period 1 Day -1.
23)Subject with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid amplification test between Period 1 Day -8 and Day -1, or clinical symptoms suggestive of infection with SARS-CoV-2.
24)Subject who is in the opinion of the investigator unsuitable in any other way to participate in this study.

Related Information

• Primary Sponsor: Hamatani Tatsuto