NCT02894541

Brief Summary

The purpose of this study is to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2016

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

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 23, 2017

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

September 5, 2016

Last Update Submit

February 21, 2017

Conditions

Healthy Volunteers

Keywords

DyslipidemiaCKD-519CETP inhibitorFood Drug Interaction

Outcome Measures

Primary Outcomes (7)

  • Cmax of CKD-519

    0(predose)~168

  • AUClast of CKD-519

    0(predose)~168

  • Tmax of CKD-519

    0(predose)~168

  • AUCinf of CKD-519

    0(predose)~168

  • T1/2 of CKD-519

    0(predose)~168

  • CL/F of CKD-519

    0(predose)~168

  • Vd/F of CKD-519

    0(predose)~168

Secondary Outcomes (1)

  • Inhibition of CETP(Cholesteryl ester transfer protein) Activity

    0(predose)~168

Study Arms (4)

CKD-519 tablet 100mg

EXPERIMENTAL

CKD-519 tablet(formulation Ⅱ) 100mg(100mg X 1Tab) Period 1: CKD-519 100mg in fasted state Period 2:CKD-519 100mg with a standard meal Period 3:CKD-519 100mg with a high fat meal

Drug: CKD-519 100mg

CKD-519 tablet 200mg

EXPERIMENTAL

CKD-519 tablet(formulation Ⅱ) 200mg(100mg X 2Tabs) Period 1:CKD-519 200mg in fasted state Period 2:CKD-519 200mg with a standard meal Period 3:CKD-519 200mg with a high fat meal

Drug: CKD-519 200mg

CKD-519 soft capsule 100mg

EXPERIMENTAL

CKD-519 soft capsule(formulation Ⅲ) 100mg(100mg X 1Cap) Period 1:CKD-519 100mg in fasted state Period 2:CKD-519 100mg with a standard meal Period 3:CKD-519 100mg with a high fat meal

Drug: CKD-519 100mg

CKD-519 soft capsule 200mg

EXPERIMENTAL

CKD-519 soft capsule(formulation Ⅲ) 200mg(100mg X 2Caps) Period 1:CKD-519 200mg in fasted state Period 2:CKD-519 200mg with a standard meal Period 3:CKD-519 200mg with a high fat meal

Drug: CKD-519 200mg

Interventions

CKD-519 100mgDRUG
Also known as: CKD-519 tablet(formulation Ⅱ) 100mg(100mg X 1Tab)
CKD-519 tablet 100mg
CKD-519 200mgDRUG
Also known as: CKD-519 tablet(formulation Ⅱ) 200mg(100mg X 2Tabs)
CKD-519 tablet 200mg

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 20 aged and 45 aged in healthy adult male
  • Body weight more than 50, Body Mass Index between 18 and 29kg/m²
  • Necessarily he agrees that use double contraceptions 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:

  • Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system
  • Have a acute disease within 28 days before the beginning of study treatment
  • Have a disease history that can effect drug absorption, distribution, metabolism, excretion
  • Have a clinically significant chronic disease
  • Systolic blood pressure\<100mmHg or\>140mmHg, diastolic blood pressure\<60mmHg or\>90mmHg
  • Defined by the following 12-lead ECG, QTc\>450msec
  • Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories))
  • Subject treated ethical drug within 14 days before the beginning of study treatment
  • Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment
  • Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs)
  • Cannot take standard Meal
  • Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing
  • Blood transfusion within 30 days
  • Taking drugs have received any other investigational drug within 90 days prior to the first dosing
  • Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea university medical center

Seoul, Sungbuk-gu, 136-705, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

CKD-519

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ji Young Park, MD, PhD

    Korea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 9, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

February 23, 2017

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)