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

NCT02007941 | Completed Phase 1

• 1 other identifier: 19RI113017
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Impairment; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The pharmacokinetic( Cmax, AUCt ) of main metabolites(M7) of CKD-501 Between Renal Impaired patients and Normal Renal function subjects

  0-48 hrs

Study Arms (3)

End Stage Renal Disease(ESRD)

EXPERIMENTAL

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

normal renal function

ACTIVE COMPARATOR

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

Mild renal impairment

EXPERIMENTAL

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

Drug: CKD-501

Interventions

CKD-501 DRUG

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

Also known as: Lobeglitazone

End Stage Renal Disease(ESRD); Mild renal impairment; normal renal function

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

The Inje University Busan Paik Hospital

Busan, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

lobeglitazone

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jae Kuk Shin, Ph.D. M.D

  The Inje University Busan Paik Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 11, 2013
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

KR (1)