Comparative Evaluation of Pharmacokinetics After CKD-501 Between Renal Impaired and Normal Renal Function Subjects

Study Overview
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Brief Summary
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The purpose of this study is to assess between the renal impaired patients and normal renal function subjects comparetive evaluation to Pharmacokinetics after CKD-501 Future, When prescription CKD-501 to renal impaired patient, It will be guidelines to provide a basis of instructions.

Detailed Description
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A Phase 1, Non-randomized, Open, Parallel-Group Clinical trial

Official Title
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An Open-label, Non-randomized, Parallel-group Design Clinical Trial for Comparative Evaluation of Pharmacokinetics After CKD-501 Between Patients With Renal Impairment and Control Subjects With Normal Renal Function

Conditions
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Renal Impairment, Healthy

Intervention / Treatment
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* Drug: CKD-501


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria All subjects: Adult males or females, 20 - 65 years of age (inclusive); Body mass index (BMI) range of approximately 18.5-29.9 kg/㎡ (inclusive); Agreement with written informed consent Agree to Medically acceptable method of contraception during clinical trials Normal Renal Function subjects: Matched to renal impaired patients(ESRD) in the study by age (±7 years), sex and BMI Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, EKG, physical examination); eGFR ≥ 90 mL/min/1.73mE2; Renally impaired subjects: Matched to renal impaired patients(ESRD) in the study by age (±7 years), sex and BMI Subjects with mild renal impairment (eGFR 60-89 mL/min/1.73mE2) OR moderate renal impairment (eGFR 30-59 mL/min/1.73mE2) OR severe renal impairment (eGFR 15-29 mL/min/1.73mE2) OR dialysis end stage renal disease(ESRD) Exclusion Criteria All subjects: The subject's systolic blood pressure is outside the range of 100-180mmHg, or diastolic blood pressure is outside the range of 50-110mmHg Repeatedly Screening ECG parameters (PR ≥ 210 mse,QRS ≥ 120 msec, QTcF ≥ 500 msec) Repeatedly lab(AST >1.25xULN, ALT>1.25xULN ,Total bilirubin >1.5xULN) A positive pre-study drug screen.(amphetamines, barbiturates, cocaine, opiates, cannabinoids, benzodiazepin) Clinically significant allergic diseases or History of thiazolidinedione class's anaphylaxis reactions Can not stop to be taking caffeine (caffeine > 400mg/day), drinking(alcohol > 30 g/day) or severe heavy smoker(cigarette > 10 cigarettes/day) during clinical trials Consumption of food which may affect study within 7 days prior to first dose of study medication or taking a dietary supplement now or continued. Consumption of drug which may affect study within 7 days prior to first dose of study medication. Previously donate whole blood within 60 days or component blood within 30 days prior to first dose of study medication. blood transfusion within 30 days prior to first dose of study medication. Subjects with participation in another clinical trial within 60 days prior to the study An impossible one who participates in clinical trial by Principal investigator's decision Normal Renal Function subjects: Subjects with a history of chronic disease or an acute illness within 28 days of study medication administration Subjects with a history of gastrointestinal disease effected study medication or surgery(except appendectomy, hernia surgery) Current or chronic history of liver disease or ascites or hepatic encephalopathy Renally impaired subjects: Type I diabetes, Diabetic ketoacidosis, diabetic coma or a history of coma (controllable Type II diabetes including possible) Uncontrollable hypertension or severe heart failure require treatment with steroid or immunosuppressive drug History of renal transplant or undergoing other dialysis method except hemodialysis Needs treatment for acute disease, uncontrolled other disease or diabetic complications Current or chronic history of liver disease or ascites or hepatic encephalopathy Subjects with a history of chronic disease or an acute illness within 28 days of study medication administration Subjects with a history of gastrointestinal disease effected study medication or surgery(except appendectomy, hernia surgery)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: End Stage Renal Disease(ESRD)<br>CKD-501 will be administered to patients who have required dialysis and non-dialysis eGFR(estimate glomerular filtration rate ) is Less than 15. First, ESRD Patient and normal renal function Subjects are conducted. After the interim analysis, Determine whether early termination or renal impaired subject's progress | Drug: CKD-501<br>* From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .<br>* Other names: Lobeglitazone;|
| Active Comparator: normal renal function<br>CKD-501 will be administered to normal renal function subject who have eGFR(estimate glomerular filtration rate ) of 90 or more. First, ESRD Patient and normal renal function Subjects are conducted. After the interim analysis, Determine whether early termination or renal impaired subject's progress | Drug: CKD-501<br>* From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .<br>* Other names: Lobeglitazone;|
| Experimental: Mild renal impairment<br>CKD-501 will be administered to patients who have eGFR(estimate glomerular filtration rate ) is 60 to 89 that. | Drug: CKD-501<br>* From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .<br>* Other names: Lobeglitazone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic( Cmax, AUCt ) of lobeglitazone(CKD-501) Between Renal Impaired patients and Normal Renal function subjects | Blood sampling timepoint : (Day 1) 0hr, 0.33hr, 0.66hr, 1hr, 1.5hr, 2hr, 3hr, 6hr, 12hr, 24hr (Day 2)36hr (Day3)48hr- total 12 timepoints per period Additional Blood sampling for unbound fraction analysis : (Day 1) 1hr, 6hr, 12hr Urine collection : (Day 1)0-6hr, 6-12hr, 12-24hr (Day 2) 24-36hr, 36-48hr | 0-48 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic( Cmax, AUCt ) of main metabolites(M7) of CKD-501 Between Renal Impaired patients and Normal Renal function subjects | Blood sampling timepoint : (Day 1) 0hr, 0.33hr, 0.66hr, 1hr, 1.5hr, 2hr, 3hr, 6hr, 12hr, 24hr (Day 2)12hr (Day3)0hr- total 12 timepoints per period Urine collection : (Day 1)0-6hr, 6-12hr, 12-24hr (Day 2) 24-36hr, 36-48hr | 0-48 hrs |