Pharmacokinetics Study in Patients With Impaired Hepatic Function

Exclusion Criteria

• •A subject will be excluded from participation in this study if any of the following apply:
• •All subjects:
• •Received or is scheduled to receive any investigational drugs in other clinical trials, post-marketing studies or clinical research within 120 days before screening or during the period from screening to the hospital admission.
• •Excessive alcohol or smoking habit.
• •Applies to any of following concerns of tuberculosis:
• •* A history of active tuberculosis
• •* Abnormalities detected on a chest X-ray test (at screening)
• •* Contact with infectious tuberculous patients
• •Applies to any of following concerns except for tuberculosis:
• •* Concurrent or previous severe herpes zoster or herpes zoster disseminated
• •* More than 1 recurrence of localized herpes zoster
• •* Inpatient hospital care for severe infectious disease within 90 days before the hospital admission
• •* Treatment with intravenous antibiotics within 90 days before the hospital admission (prophylactic antibiotics are not applicable)
• •* Other than above, a people who has a risk of developing infectious diseases (e.g. urethral catheterisation) in judgment of the investigator/subinvestigator
• •Vaccination of live vaccines or live attenuated vaccines within 56 days before the hospital admission (inactivated vaccines such as influenza vaccine and pneumococcal vaccine are not applicable).
• •Concurrent or previous drug allergies.
• •A history of clinically serious allergies (serious allergies: Generalised urticaria which requires hospital admission, allergy which causes anaphylactic shock, etc.).
• •Concurrent or previous cardiac failure NYHA class 3 or 4, long QT syndrome and congenital short QT syndrome.
• •Development of (an) upper gastrointestinal symptom(s) within 7 days before the hospital admission.
• •Concurrent or previous lymphatic disease.
• •A history of digestive tract excision, except for a history of appendectomy.
• •Previous use of ASP015K.
• •A patient with impaired hepatic function:
• •Unable to start washout of concomitant prohibited medications from at least 14 days prior to the study drug administration.
• •Concurrent uncontrolled hypertension.
• •Clinically significant abnormality detected on standard 12-lead electrocardiogram at screening or hospital admission.
• •eGFR by the GFR estimating equation for Japanese \<45 mL/min/1.73 m2 (the first decimal place rounded off) at screening.
• •Uncontrolled ascites or pleural effusion observed at screening.
• •Concurrent hepatic encephalopathy Coma Scale II or more at screening.
• •Underwent hepatic transplantation, or underwent hepatectomy within 1 year before screening.
• •Concurrent or previous drug-induced hepatic disorder.
• •Concurrent acute hepatic disease.
• •With surgically-placed portosystemic shunts including transjugular intrahepatic portosystemic shunts.
• •Concurrent biliary obstruction.
• •A history of oesophageal haemorrhage or gastric varices haemorrhage within 180 days before screening.
• •Irregular or acute, and clinically significant LFT values or changes in clinical symptoms from 30 days before screening to immediately before study drug administration.
• •Platelet count \<4 × 104/μL, or haemoglobin \<9 g/dL at screening.
• •Alcohol dependence or unable to remain abstinent during the specified period.
• •Concurrent esophagus or gastric varices which have a high risk of clinically significant haemorrhage.
• •Concurrent cerebrovascular disorder, serious heart disease, malignant tumour or a history within 5 years before screening, gastrointestinal disease, urinary disease, renal disease, endocrine disease, and respiratory disease.
• •A subject with normal hepatic function:
• •Received or is scheduled to receive medications (including over-the-counter drugs) within 7 days before the hospital admission.
• •Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram at screening or the hospital admission.
• •Meets any of the criteria for laboratory tests at screening or the hospital admission.
• •eGFR by the GFR estimating equation for Japanese \<60 mL/min/1.73 m2 (the first decimal place rounded off) at screening.
• •Concurrent or previous hepatic disease, cerebrovascular disorder, malignant tumor, heart disease, gastrointestinal disease, except for a history of appendicitis, renal disease, endocrine disease, respiratory disease, urological disease.