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

NCT ID: NCT02007941

Last Updated: 2016-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-04-30

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

Conditions

Renal Impairment; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CKD-501

Intervention Type: DRUG

From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .

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

Group Type: ACTIVE_COMPARATOR

CKD-501

Intervention Type: DRUG

From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .

Mild renal impairment

CKD-501 will be administered to patients who have eGFR(estimate glomerular filtration rate ) is 60 to 89 that.

Group Type: EXPERIMENTAL

CKD-501

Intervention Type: DRUG

From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .

Interventions

CKD-501

From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .

Intervention Type: DRUG

Other Intervention Names

Lobeglitazone

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae Kuk Shin, Ph.D. M.D

Role: PRINCIPAL_INVESTIGATOR

The Inje University Busan Paik Hospital

Locations

The Inje University Busan Paik Hospital

Busan, , South Korea

Countries

South Korea

Other Identifiers

19RI113017

Identifier Type: -

Identifier Source: org_study_id