NCT02916901

Brief Summary

The purpose of this study is to determine influence of CKD-519 on 24-h ambulatory blood pressure after oral administration in healthy adult volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 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
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3 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

September 1, 2016

Enrollment Period

2 months

First QC Date

September 20, 2016

Last Update Submit

February 20, 2017

Conditions

Healthy Volunteers

Keywords

DyslipidemiaCKD-519CETP inhibitorABPM

Outcome Measures

Primary Outcomes (1)

  • Change in 24h average SBP and DBP from baseline to Day 14 Each time point is as following: Daytime: 06:00~21:59 Nighttime: 22:00~05:59

    14days

Secondary Outcomes (3)

  • Cmax,ss of CKD-519

    0(predose)~24 at day15

  • AUCτ,ss of CKD-519

    0(predose)~24 at day15

  • Tmax,ss of CKD-519

    0(predose)~24 at day15

Study Arms (2)

CKD-519 200mg

EXPERIMENTAL

CKD-519 tab(formulation II) 200mg (100mg X 2tabs)

Drug: CKD-519 200mg

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

CKD-519 200mgDRUG
Also known as: (formulation II) 200mg (100mg X 2tabs)
CKD-519 200mg
PlaceboDRUG
Placebo

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 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
  • Sitting SBP \> 140mmHg or \< 90mmHg, sitting DBP \> 90mmHg or \< 60mmHg, after 5 minutes break.
  • The difference in DBP\>10mmHg or SBP \>20mmHg at the screening period
  • 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),
  • smoker(except the one who have stopped smoking more than 90days before beginning of study treatment)
  • +7 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 Officials

  • Min Soo Park, MD, PhD

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 20, 2016

First Posted

September 28, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2016

Study Completion

January 1, 2017

Last Updated

February 23, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)