A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function

A Phase 1, Non-randomized, Open, Parallel-Group study.

A. Inclusion Criteria

[The subjects with impaired hepatic function]

• The subjects who are 19 to 64 years old
• The subjects with stable hepatic disease and impaired hepatic function as Child-Pugh A or B
• Body Weight ≥ 55kg
• If females, Negative for pregnancy test at the screening and pre dose of Day 1
• The subjects who agreed with performing contraception during the study
• The subjects who agreed with written informed consent

[The subjects with normal hepatic function]

• The subjects who are 19 to 64 years old
• The subjects who are matched impaired hepatic function by gender, age(± 5years) and body weight(± 10kg)
• If females, Negative for pregnancy test at the screening and pre dose of Day 1
• The subjects who agreed with performing contraception during the study
• The subjects who agreed with written informed consent

B. exclusion criteria

[The subjects with impaired hepatic function]

• The subjects with impaired hepatic function as Child-Pugh C
• The subjects had a portosystemic shunt surgery
• The subjects had a liver transplantation or unsuitable for the study by the investigator's judgement(for examples, hepatic encephalopathy grade 3 or 4, stroke, heart failure, cancer etc.) but The subject is eligible to participate if had not chemotherapy or radiofrequency ablation therapy within 6months)
• The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product
• The subjects who took drugs or medicine which can be effected in metabolism of Cytochrome P450 within 14days prior to Day 1
• Positive for anti-HIV Ab or venereal disease research laboratory etc.

[The subjects with normal hepatic function]

• The subjects with liver disease or abnormal Laboratory test(Asparate transaminase >1.25 fold of upper normal limit, Alanine transaminase>1.25 fold of upper normal limit, Total bilirubin >1.5 fold of upper normal limit)
• The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product
• Estimated Glomerular filtration rate < 60 mL/min/1.73m2 by Modification of Diet in Renal Disease formula
• Positive for HBsAg, anti-Hepatitis C virus Ab, anti-HIV Ab or venereal disease research laboratory
• The subjects with high blood pressure or low blood pressure(systolic blood pressure >150mmHg or <100mmHg, diastolic blood pressure>90mmHg or <60mmHg)
• The subjects who took drugs or medicine which can be effected in metabolism of Cytochrome P450 within 14days prior to Day 1 etc.