NCT03210649

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

June 2, 2017

Last Update Submit

July 6, 2017

Conditions

Dyslipidemia

Keywords

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Pharmacodynamics(Lipid Parameter) of CKD-519

    PartⅡ- Day1, Day3, Day7, Day10, Day12, Day14, Day15, Day16, Day17, Day21

  • Pharmacodynamics(CETP) of CKD-519

    Day1: 0(predose)~168hour

  • Pharmacodynamics(QC/QTc) of CKD-519

    Part II - Day-1, Day 1, Day14

Other Outcomes (1)

  • Area Under the Curve [AUC] [Cmax] of CKD-519

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

Study Arms (2)

CKD-519 400mg(PartⅠ: 1day)

EXPERIMENTAL

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

Drug: CKD-519Drug: Placebo

CKD-519 400mg(PartⅡ: 14days)

EXPERIMENTAL

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

Drug: CKD-519Drug: Placebo

Interventions

CKD-519DRUG

Part 1 : CKD-519(100mg x 4 Tablets) for D1 Part 2 : CKD-519(100mg x 4 Tablets) for D1\~D14

CKD-519 400mg(PartⅠ: 1day)CKD-519 400mg(PartⅡ: 14days)
PlaceboDRUG

Part 1 : CKD-519 placebo(100mg x 4 Tablets) for D1 Part 2 : CKD-519 placebo(100mg x 4 Tablets) for D1\~D14

CKD-519 400mg(PartⅠ: 1day)CKD-519 400mg(PartⅡ: 14days)

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seodaemun-gu, 120-752, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

CKD-519

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2017

First Posted

July 7, 2017

Study Start

March 7, 2017

Primary Completion

April 24, 2017

Study Completion

April 24, 2017

Last Updated

July 7, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)