Subjects with impaired hepatic function
Conditions
Sponsors
EA Pharma Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [ Common criteria for all subjects ] - Japanese - A BMI of >=18.5 to <30.0 kg/m2 in the examinations at screening and on the day before administration of the investigational product - Able to consent in writing to participate in this clinical study based on his/her own free will and to comply with the requirements in this study [ Criteria exclusively for subjects with normal hepatic function ] - Individuals with ALP, AST, ALT, gamma-GTP, and total bilirubin within the normal reference range in the laboratory tests at screening and on the day before administration of the investigational product - Individuals deemed by the investigator or subinvestigator to have no clinically significant abnormalities based on medical examination findings, vital signs, electrocardiogram, and laboratory tests and having no problems participating in this clinical study - Individuals who demographically resemble the subjects with impaired hepatic function enrolled in this clinical study [ Criteria exclusively for subjects with impaired hepatic function ] - Individuals diagnosed before informed consent based on liver biopsy, laparoscopy, or diagnostic imaging, etc. with hepatic cirrhosis classified as Child-Pugh Classification A or B at screening - Mild hepatic impairment: Child-Pugh classification A (5 to 6 points) - Moderate hepatic impairment: Child-Pugh classification B (7 to 9 points) - Individuals whose hepatic impairment can be deemed to be in a stable state by the investigator or subinvestigator
Exclusion criteria
Exclusion criteria: [ Common criteria for all subjects ] - Having undergone hepatic transplant surgery -Having undergone hepatectomy, excluding enucleation, partial hepatectomy, subsegmentectomy, or segmentectomy - A history of drug allergy - Known hypersensitivity to the investigational product - A past or present medical history of disease at screening that is deemed by the investigator or subinvestigator as a cause of difficulty in completing this clinical study safely - A past or present medical history of dysfunction related to such organs as the heart, liver, kidneys, lungs, blood, or gastrointestinal tract that is considered unsuitable for study participation - An estimated glomerular filtration rate (eGFR) 450 ms on the ECG at screening - Poorly controlled psychotic disorder or unstable recurrent affective disorder at screening or attempted suicide within approximately 2 years before screening - A history of drug dependence or abuse within approximately 2 years before screening - Inability to abstain from alcohol consumption during the study period - A positive urine drug test/alcohol test at screening or on the day before administration of the investigational product - A habit of excessive smoking - Any central nervous system symptoms - A white blood cell count of 3000/micro-L or less in the laboratory tests at screening or on the day before administration of the investigational product - A medical history, within 1 year before administration of the investigational product, or of an ongoing serious infection - Use of a prohibited concomitant drug/therapy, any change in the dosage and administration of a drug used for treating the underlying disease or complications, or initiating a new treatment or therapy with drugs or vitamins within 8 days before administration of the investigational product - Intake of grapefruit, grapefruit juice, or food containing grapefruit components within 8 days before administration of the investigational product - Intake of St. John's wort or food containing its ingredients within 15 days before administration of the investigational product - Intake of a supplement containing garlic as the main ingredient within 6 weeks before administration of the investigational product - Ongoing use at screening of psychotropic drugs for recreational purposes other than treatment - Women who at screening are nursing or pregnant - In cases of a fertile man and a woman of childbearing potential, those who do not agree to practice medically appropriate contraception from the time of informed consent by the subject and his/her partner to the completion of follow-up - Women who wish to become pregnant during the period from the time of informed consent to the completion of follow-up or men with a female partner who wishes to become pregnant during the above period - Ongoing participation in another clinical study or past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety - Vital signs - ECG (standard 12-lead ECG) - Laboratory tests - Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics AJM300 and metabolites | — |
Countries
Japan
Outcome results
None listed