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

Study Overview
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Brief Summary
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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
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A Phase 1, Non-randomized, Open, Parallel-Group study.

Official Title
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A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function Compared With Normal Hepatic Function

Conditions
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Liver Dysfunction

Intervention / Treatment
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* Drug: CKD-501


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Child Pugh A<br>CKD-501 will be administered to patients who are included Child Pugh A | Drug: CKD-501<br>* CKD-501 0.5mg, PO(per oral), once<br>* Other names: Lobeglitazone;|
| Experimental: Child Pugh B<br>CKD-501 will be administered to patients who are included Child Pugh B | Drug: CKD-501<br>* CKD-501 0.5mg, PO(per oral), once<br>* Other names: Lobeglitazone;|
| Experimental: Subject who are matched Child Pugh A<br>CKD-501 will be administered to the Subjects who are matched Child Pugh A | Drug: CKD-501<br>* CKD-501 0.5mg, PO(per oral), once<br>* Other names: Lobeglitazone;|
| Experimental: Subject who are matched Child Pugh B<br>CKD-501 will be administered to the subjects who are matched Child Pugh B | Drug: CKD-501<br>* CKD-501 0.5mg, PO(per oral), once<br>* Other names: Lobeglitazone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration(last) and Cmax of CKD-501 | Sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | 0 to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax, Area Under the Concentration(inf), T1/2 and Clearance/F of CKD-501 and its metabolite | Sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | 0 to 48 hours | 
| Fraction Unbound of CKD-501 and its metabolite | sampling timepoint(hours) : 1, 8 | 1 and 8 hours | 
| Area Under the Concentration(last) and Cmax of the metabolite | sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | o to 48 hours | 
| Metabolic ratio(metabolite/CKD-501) | sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | 0 to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD-501