Clinical trial NCT02007941: Comparative Evaluation of Pharmacokinetics After CKD-501 Between Renal Impaired and Normal Renal Function Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Healthy
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-12-11
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: The pharmacokinetic( Cmax, AUCt ) of lobeglitazone(CKD-501) Between Renal Impaired patients and Normal Renal function subjects
timeFrame: 0-48 hrs
Secondary outcomes:
measure: The pharmacokinetic( Cmax, AUCt ) of main metabolites(M7) of CKD-501 Between Renal Impaired patients and Normal Renal function subjects
timeFrame: 0-48 hrs
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: The Inje University Busan Paik Hospital
Study officials:
affiliation: The Inje University Busan Paik Hospital
name: Jae Kuk Shin, Ph.D. M.D
role: PRINCIPAL_INVESTIGATOR
References: