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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT02007941
Collaborator
(none)
28
Enrollment
1
Location
3
Arms
12
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Inje University Busan Paik Hospital Busan Korea, Republic of

    Sponsors and Collaborators

    • Chong Kun Dang Pharmaceutical

    Investigators

    • Principal Investigator: Jae Kuk Shin, Ph.D. M.D, The Inje University Busan Paik Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT02007941
    Other Study ID Numbers:
    • 19RI113017
    First Posted:
    Dec 11, 2013
    Last Update Posted:
    Dec 6, 2016
    Last Verified:
    Dec 1, 2016
    Additional relevant MeSH terms:
    Renal Insufficiency

    Study Results

    No Results Posted as of Dec 6, 2016