Non-Alcoholic SteatoHepatitis(NASH)
Conditions
Interventions
Cohort 1: IVA337 400 mg per patient will be administered orally once daily under fasting conditions.
Cohort 2: Patients will be randomized in a 3:1 ratio to receive 800 mg IVA337 or 800 mg placebo per
Sponsors
Nakamura Yoshihide
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in the study. 1.Healthy Japanese men aged 18 to 45 years at the time of consent acquisition. 2.Body mass index (BMI) at screening >= 18.5 kg/m2 and < 25.0 kg/m2. 3.Patients who are considered healthy by the investigator or subinvestigator based on medical history, physical findings, 12 lead electrocardiogram, vital signs, serum and urine biochemistry, and hematology before the study. 4.Persons who are able and willing to obtain written consent 5.Men who agree to the requirement not to provide sperm during the study and for 90 days after the last dose of the study drug 6.Men who comply with the requirement to use a highly effective contraceptive method if their partner is fertile during the study and for 90 days after the last dose of the study drug
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are excluded from inclusion in the study. 1.Patients with respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neoplastic (Including leukemia, lymphoma, and malignant melanoma), myeloproliferative, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immune, skin, or connective tissue diseases or physical disorders, or who have a history or complications of a disease that could interfere with the interpretation of the study results, have been prescribed a therapeutic drug, or that the investigator or subinvestigator considers to pose an additional risk by participating in the study. 2.Patients who underwent major surgery or donated/lost more than 1 unit (Approximately 400 mL of whole blood, or 600 mL for component blood donation) within 84 days prior to admission to the study site (CRU) or who donated plasma within 7 days prior to admission to the CRU. 3.Patients who used dietary supplements/St. John's wort or over-the-counter drugs or other supplements containing regularly consumed vitamins or minerals within 7 days prior to admission to the CRU or within 5 half-lives (If known, whichever is longer). 4.Patients who tested positive for hepatitis B surface antigen, HCV antibody, HIV antigen/antibody, or syphilis test (TP antibody, RPR) at screening. 5.Patients who had a documented diagnosis of autoimmune hepatitis. 6.Patients who had any of the following clinically significant ECG abnormalities at screening or admission: a.Grade II or III atrioventricular block. b.Cardiac rhythm other than sinus rhythm. c.QRS interval >= 130 ms. d.Heart rate < 40 beats/min after 10 minutes in the supine resting position. e.Significant morphologic changes (including flat T waves) other than minor non-specific T wave changes that are interpreted as clinically significant by the investigator or subinvestigator. (Note: A repeat test may be performed after at least 30 minutes if the ECG is abnormal to confirm eligibility) 7.History or known family history of: a.Myocardial infarction, acute coronary syndrome, cerebrovascular accident, transient ischemic attack, ventricular or atrial tachyarrhythmias, syncope of known cause but not resolved, congenital long QT syndrome b.Known family history of sudden unexplained death c.History of pacemaker or implantable cardioverter defibrillator, cardiac or carotid artery/brain stenting or angioplasty, or clinically significant valvular heart disease 8.History of drug dependence* within 2 years prior to screening (Amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) and alcohol dependence; positive drug abuse test, alcohol test, or cotinine test at screening and admission *Drug dependence is defined as compulsive, repetitive, and/or chronic use of drugs or other substances, whether or not there are use-related problems 9.Persons who consume excessive alcohol or do not intend to abstain from alcohol from 48 hours prior to admission to the CRU until the end of the study. Excessive alcohol is defined as more than 3 units of alcoholic beverages per day, and 1 unit corresponds to approximately 350 mL of beer, 150 mL of wine, or 45 mL of distilled liquor. 10.Persons who do not intend to abstain from caffeine or xanthine-containing products (For example, caffeinated tea, coffee, chocolate, cola, etc.) from 48 hours prior to admission to the CRU until the end of the study 11.Consumed grapefruit, Seville orange, and/o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event reports, vital signs measurements, electrocardiograms, physical examinations, and laboratory tests. | — |
Contacts
Public ContactYoshihide Nakamura
Hepalys Pharma Inc.
Outcome results
None listed