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
Overview
- Phase
- Phase 1
- Intervention
- CKD-501
- Conditions
- Renal Impairment
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- The pharmacokinetic( Cmax, AUCt ) of lobeglitazone(CKD-501) Between Renal Impaired patients and Normal Renal function subjects
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
End Stage Renal Disease(ESRD)
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
Intervention: CKD-501
normal renal function
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
Intervention: CKD-501
Mild renal impairment
CKD-501 will be administered to patients who have eGFR(estimate glomerular filtration rate ) is 60 to 89 that.
Intervention: CKD-501
Outcomes
Primary Outcomes
The pharmacokinetic( Cmax, AUCt ) of lobeglitazone(CKD-501) Between Renal Impaired patients and Normal Renal function subjects
Time Frame: 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 Outcomes
- The pharmacokinetic( Cmax, AUCt ) of main metabolites(M7) of CKD-501 Between Renal Impaired patients and Normal Renal function subjects(0-48 hrs)