Healthy, Renal Impairment
Conditions
Brief summary
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
A Phase 1, Non-randomized, Open, Parallel-Group Clinical trial
Interventions
DRUGCKD-501
From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The pharmacokinetic( Cmax, AUCt ) of lobeglitazone(CKD-501) Between Renal Impaired patients and Normal Renal function subjects | 0-48 hrs | * 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The pharmacokinetic( Cmax, AUCt ) of main metabolites(M7) of CKD-501 Between Renal Impaired patients and Normal Renal function subjects | 0-48 hrs | * 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 |
Countries
South Korea
Outcome results
None listed