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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007941
• Other study ID #: 19RI113017
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2013
• Last updated: December 4, 2016
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: December 2016
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy
• Renal Impairment
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	The Inje University Busan Paik Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No