Liver Dysfunction
Conditions
Keywords
CKD-501
Brief summary
The purpose of this study is to evaluate pharmacokinetics of CKD-501 in patients with impaired hepatic function compared with normal hepatic function.
Detailed description
A Phase 1, Non-randomized, Open, Parallel-Group study.
Interventions
DRUGCKD-501
CKD-501 0.5mg, PO(per oral), once
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
A. Inclusion Criteria \[The subjects with impaired hepatic function\] 1. The subjects who are 19 to 64 years old 2. The subjects with stable hepatic disease and impaired hepatic function as Child-Pugh A or B 3. Body Weight ≥ 55kg 4. If females, Negative for pregnancy test at the screening and pre dose of Day 1 5. The subjects who agreed with performing contraception during the study 6. The subjects who agreed with written informed consent \[The subjects with normal hepatic function\] 1. The subjects who are 19 to 64 years old 2. The subjects who are matched impaired hepatic function by gender, age(± 5years) and body weight(± 10kg) 3. If females, Negative for pregnancy test at the screening and pre dose of Day 1 4. The subjects who agreed with performing contraception during the study 5. The subjects who agreed with written informed consent B.
Exclusion criteria
\[The subjects with impaired hepatic function\] 1. The subjects with impaired hepatic function as Child-Pugh C 2. The subjects had a portosystemic shunt surgery 3. 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) 4. The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product 5. The subjects who took drugs or medicine which can be effected in metabolism of Cytochrome P450 within 14days prior to Day 1 6. Positive for anti-HIV Ab or venereal disease research laboratory etc. \[The subjects with normal hepatic function\] 1. 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) 2. The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product 3. Estimated Glomerular filtration rate \< 60 mL/min/1.73m2 by Modification of Diet in Renal Disease formula 4. Positive for HBsAg, anti-Hepatitis C virus Ab, anti-HIV Ab or venereal disease research laboratory 5. The subjects with high blood pressure or low blood pressure(systolic blood pressure \>150mmHg or \<100mmHg, diastolic blood pressure\>90mmHg or \<60mmHg) 6. The subjects who took drugs or medicine which can be effected in metabolism of Cytochrome P450 within 14days prior to Day 1 etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration(last) and Cmax of CKD-501 | 0 to 48 hours | Sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax, Area Under the Concentration(inf), T1/2 and Clearance/F of CKD-501 and its metabolite | 0 to 48 hours | Sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 |
| Fraction Unbound of CKD-501 and its metabolite | 1 and 8 hours | sampling timepoint(hours) : 1, 8 |
| Area Under the Concentration(last) and Cmax of the metabolite | o to 48 hours | sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 |
| Metabolic ratio(metabolite/CKD-501) | 0 to 48 hours | sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 |
Other
| Measure | Time frame |
|---|---|
| Physical examination | up to 8 days |
| Laboratory tests | up to 8 days |
| Adverse events | up to 8 days |
| Vital signs | up to 8 days |
Countries
South Korea
Outcome results
None listed