Clinical Trials/NCT03210649

NCT03210649

Completed

Phase 1

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

Chong Kun Dang Pharmaceutical1 site in 1 country18 target enrollmentMarch 7, 2017

ConditionsDyslipidemia

InterventionsCKD-519 Placebo

DrugsCKD-519 Placebo

Overview

Phase: Phase 1
Intervention: CKD-519
Conditions: Dyslipidemia
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 18
Locations: 1
Primary Endpoint: Maximum Plasma Concentration [Cmax] of CKD-519
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

March 7, 2017

End Date

April 24, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

CKD-519 400mg(PartⅠ: 1day)

CKD-519 400mg(100mg x 4tabs) or placebo

Intervention: CKD-519

CKD-519 400mg(PartⅠ: 1day)

CKD-519 400mg(100mg x 4tabs) or placebo

Intervention: Placebo

CKD-519 400mg(PartⅡ: 14days)

CKD-519 400mg(100mg x 4tabs) or placebo

Intervention: CKD-519

CKD-519 400mg(PartⅡ: 14days)

CKD-519 400mg(100mg x 4tabs) or placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Maximum Plasma Concentration [Cmax] of CKD-519

Time Frame: Part I - Day1: 0(predose)~168hour, Part II - Day1: 0(predose)~24hour, Day3~Day13:0(predose), Day14: 0(predose)~168hour

Pharmacokinetics after administration of single and multiple doses

Secondary Outcomes

Pharmacodynamics(Lipid Parameter) of CKD-519(PartⅡ- Day1, Day3, Day7, Day10, Day12, Day14, Day15, Day16, Day17, Day21)
Pharmacodynamics(QC/QTc) of CKD-519(Part II - Day-1, Day 1, Day14)
Pharmacodynamics(CETP) of CKD-519(Day1: 0(predose)~168hour)