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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Renal Impairment
• Intervention / Treatment: Drug: CKD-501

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • The Inje University Busan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: CKD-501; From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .; Other Names: Lobeglitazone
ACTIVE_COMPARATOR: 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	Drug: CKD-501; From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .; Other Names: Lobeglitazone
EXPERIMENTAL: Mild renal impairment; CKD-501 will be administered to patients who have eGFR(estimate glomerular filtration rate ) is 60 to 89 that.	Drug: CKD-501; From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .; Other Names: Lobeglitazone

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Jae Kuk Shin, Ph.D. M.D, The Inje University Busan Paik Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (ESTIMATE): December 11, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: 19RI113017