Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519

Detailed Description
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A randomized, double-blind, placebo-controlled, phase I clinical trial to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519 after oral administration in healthy adult volunteers Part I- single dosing / Part II- multiple dosing

Official Title
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A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519 After Oral Administration in Healthy Adult Volunteers : Part I- Single Dosing / Part II- Multiple Dosing

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: CKD-519
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 19 aged and 55 aged in healthy adult Body weight more than 55kg in male, 50kg in female Body Mass Index more than 18.5 and under 25(body mass index=kg/m2) If female, must include more than one among the items The menopause(there is no natural menses for at least 2 years) Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms and do not sperm donation until two months during clinical trials and after the final dosage of investigational products Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent Exclusion Criteria: Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system(heart failure, etc) or mental illness, or a history of mental disease. Have a history of Toresades de pointes(TdP) or additional risk factors for Toresades de pointes(TdP). (Family history of long QT syndrome or sudden death, heart failure, hypokalemia, etc) Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery) Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives. An impossible one who participates in clinical trial including screening tests(medical history taking, BP, 12-lead ECG, physical examination, blood&urine laboratory test result) before 28 days the taking investigational Products. Defined by the following laboratory parameters AST, ALT>1.25 upper limit of normal range Total bilirubin>1.5 upper limit of normal range CPK>1.5 upper limit of normal range eGFR(using by MDRD method)<60mL/min/1.73m2 Defined by the following 12-lead ECG HR<40 or >110bpm PR interval>220ms or ≤110ms QRS interval>120ms QTcF<300ms or >450ms Pathologic Q-waves (defined as >40ms or depth>0.5mV) Incomplete or complete bundle branch block Pre-excitation (e.g., Wolfe-Parkinson-White Syndrome) Atrial fibrillation/flutter Second- or third-degree atrioventricular (AV)block Investigator judges to be unfavorable for consistently accurate QT measurements(e.g., indistinct QRS onset, low amplitude T wave, inverted or terminally inverted T wave, merged T/U waves, indistinct T wave offset , or prominent U wave that affects QT measurement) Sitting SBP>150mmHg or <90mmHg, sitting DBP>100mmHg or <50mmHg, after 5 minutes break. Drug abuse or have a history of drug abuse shows a positive for urine drug test. Pregnant or lactating women. A heavy caffeine consumer(caffeine>5 cups/day), alcohol consumer (alcohol>210g/week), or smoker(cigarette>10 cigarettes/day) Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of subjects. Subject who takes inhibitor and inducers of drug metabolizing enzyme (Barbiturates etc.) within 30 days. Taking concomitant medications that prolong the QT/QTc interval within 14 days before the beginning of study treatment. Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7days before the beginning of study treatment) Subject who treated with any investigational drugs within 90 days before the beginning of study treatment Previously donate whole blood within 60 days or component blood within 30 days. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason. Positive for Serology test(Hepatitis B, Hepatitis C, HIV)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-519 400mg(PartⅠ: 1day)<br>CKD-519 400mg(100mg x 4tabs) or placebo | Drug: CKD-519<br>* Part 1 : CKD-519(100mg x 4 Tablets) for D1 Part 2 : CKD-519(100mg x 4 Tablets) for D1 D14<br>Drug: Placebo<br>* Part 1 : CKD-519 placebo(100mg x 4 Tablets) for D1 Part 2 : CKD-519 placebo(100mg x 4 Tablets) for D1 D14<br>|
| Experimental: CKD-519 400mg(PartⅡ: 14days)<br>CKD-519 400mg(100mg x 4tabs) or placebo | Drug: CKD-519<br>* Part 1 : CKD-519(100mg x 4 Tablets) for D1 Part 2 : CKD-519(100mg x 4 Tablets) for D1 D14<br>Drug: Placebo<br>* Part 1 : CKD-519 placebo(100mg x 4 Tablets) for D1 Part 2 : CKD-519 placebo(100mg x 4 Tablets) for D1 D14<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration [Cmax] of CKD-519 | Pharmacokinetics after administration of single and multiple doses | Part I - Day1: 0(predose) 168hour, Part II - Day1: 0(predose) 24hour, Day3 Day13:0(predose), Day14: 0(predose) 168hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics(Lipid Parameter) of CKD-519 | simultaneous with laboratory test after multiple administration | PartⅡ- Day1, Day3, Day7, Day10, Day12, Day14, Day15, Day16, Day17, Day21 | 
| Pharmacodynamics(CETP) of CKD-519 | Pharmacodynamics after administration of single and multiple doses | Day1: 0(predose) 168hour | 
| Pharmacodynamics(QC/QTc) of CKD-519 | Pharmacokinetics after multiple administration | Part II - Day-1, Day 1, Day14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia