Comparative Evaluation of Pharmacokinetics After CKD-501 Between Renal Impaired and Normal Renal Function Subjects
Renal Impairment, Healthy
About this trial
This is an interventional treatment trial for Renal Impairment
Eligibility Criteria
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)
Sites / Locations
- The Inje University Busan Paik Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
End Stage Renal Disease(ESRD)
normal renal function
Mild renal impairment
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
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
CKD-501 will be administered to patients who have eGFR(estimate glomerular filtration rate ) is 60 to 89 that.