Liver Dysfunction
Conditions
Interventions
moderate hepatic impairment:Morinidazole 500mg single dose
matched healhy :Morinidazole 500mg single dose
Sponsors
Antibiotic Research Institute, Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects with hepatic impairment 1. Patients in stable condition with moderate impaired hepatic function, due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cirrhosis or other causes, and determined to be level B according to Child-Pugh classification; 2. Has stable regimen of treatment of hepatic function impaired for 2 weeks prior to enrollment; 3. Male or female aged 18 to 65 years; 4. For male, has a body weight = 50kg, while for female, has a body weight =45kg; 5. Agree stay in ward prior to dosing within 48h until study completed, and agree not to smooke or take caffeine, alcohol, fruit juice; 6. HCG test negative in female volunteers, volunteers must agree to use medical accepted method of birth control during the study; 7. Can sign informed consent form on his own accord. Healthy subjects without hepatic impairment: 1. Must be in good health as determined by screening medical history, physical examination, vital signs, laboratory test, B ultrasonography, chest X ray, 12-lead electrocardiograms, HbsAg and HIV test; 2. Male or female volunteers (matched to a subject with hepatic impairment in gender); 3. Aged 18 to 70 years (matched to a subject with hepatic impairment±5 years); 4. Has a body weight of = 50kg(male) and = 45kg (female)(matched to a subject with hepatic impairment±15%) 5. Agree stay in ward prior to dosing within 48h until study completed, and agree not to smoke or take caffeine, alcohol, fruit juice; 6. HCG test negative in female volunteers, volunteers must agree to use medical accepted method of birth control during the study; 7. Can sign informed consent form on his own accord.
Exclusion criteria
Exclusion criteria: Subjects with hepatic impairment 1. Has known or suspected allergies to nitroimidazoles, or allergic constitution; 2. Has acute disease or chronic disease which may affect PK profile of drug in vivo except the disease caused hepatic impaired function; 3. Has abnormal result of laboratory tests with clinical significance except which caused by the disease of hepatic function impaired; 4. Has history of clinically significant cardiovascular, neurological or psychiatric, gastrointestinal, pulmonary, renal, endocrine disease prior to study within 1 year; 5. ALT>2×ULN and/or total bilirubin>3×ULN; 6. Drug abuse; 7. Use of another investigational drug or drug which can damage hepatic function within 3 months prior to dosing; 8. Use of drugs affect function of liver metabolism enzyme within 30 days prior to dosing; or need to take medications which may affect the PK profile of investigational drug during the study; 9. HIV test positive. Healthy subjects without hepatic impairment: 1. Has known or suspected allergies to nitroimidazoles, or allergic constitution; 2. Alcoholism, long-term smoker, drug abuse; 3. Donated blood or use of another investigational drug within 3 months prior to dosing; 4. Has history of chronic diseases of cardiovascular, neurological or psychiatric, gastrointestinal, pulmonary, renal, endocrine; 5. Use of drugs affect function of liver metabolism enzyme within 30 days prior to dosing; or need to take medications which may affect the PK profile of investigational drug during the study; 6. Using drugs for prophylaxis or treatment; 7. HIV test positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum plasma drug concentration;time at which maximum plasma concentration;area under the plasma concentration vs. time curve;elimination half-life;mean dissolution time;total clearance of the drug from plasma;Apparent Volume of Distribution;cumulative amount of unchanged drug excreted into the urine;renal clearance of the drug from plasma;minimum plasma drug concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| AEs;vital signs;laboratory tests;physical examinatio;12-lead ECGs; | — |
Countries
China
Contacts
Public ContactYingyuan Zhang
Huashan Hosptial, Fudan University
Outcome results
None listed