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

NCT02753504 | Completed Phase 1

• 1 other identifier: 148HPS15001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dyslipidemia

Keywords

Dyslipidemia

Outcome Measures

Primary Outcomes (9)

• Cmax,ss of CKD-519

  Day1: 0(predose)~24 Day3~Day13: 0(predose) Day14: 0(predose)~168

• AUCt,ss of CKD-519

  Day1: 0(predose)~24 Day3~Day13: 0(predose) Day14: 0(predose)~168

• AUCinf,ss of CKD-519

  Day1: 0(predose)~24 Day3~Day13: 0(predose) Day14: 0(predose)~168

• Tmax,ss of CKD-519

  Day1: 0(predose)~24 Day3~Day13: 0(predose) Day14: 0(predose)~168

• T1/2 of CKD-519

  Day1: 0(predose)~24 Day3~Day13: 0(predose) Day14: 0(predose)~168

• Cmin,ss of CKD-519

  Day1: 0(predose)~24 Day3~Day13: 0(predose) Day14: 0(predose)~168

• Cavg,ss of CKD-519

  Day1: 0(predose)~24 Day3~Day13: 0(predose) Day14: 0(predose)~168

• CLss/F of CKD-519

  Day1: 0(predose)~24 Day3~Day13: 0(predose) Day14: 0(predose)~168

• accumulation ratio(D14/D1: Cmax, AUC0-t) of CKD-519

  Day1: 0(predose)~24 Day3~Day13: 0(predose) Day14: 0(predose)~168

Secondary Outcomes (5)

• CETP activity of CKD-519

  Day1: 0(predose)~24 Day3~Day13: 0(predose) Day14: 0(predose)~168

• CETP concentration of CKD-519

  Day1, 2, 6, 10, 14: 0(predose) Day15, 16, 17: Day14(24, 48, 72)

• Lipid parameter(HDL-c, LDL-c, Total Cholesterol, Triglyceride) of CKD-519

  Day1, 3, 7, 10, 12, 14: 0(predose) Day15, 16, 17, 21: Day14(24, 48, 72, 169)

• Lipid parameter(Apolipoprotein A-I, E, B) of CKD-519

  Day1, 8: 0(predose) Day15: Day14(24)

• QT/QTc(QTcF, QTcB, QT, HR, RR, PR, QRS) of CKD-519

  Baseline(Day-1): 0~12 Day1: 0~24 Day14: 0~24

Study Arms (3)

CKD-519 50mg

EXPERIMENTAL

CKD-519 50mg or placebo

Drug: CKD-519; Drug: placebo

CKD-519 100mg

EXPERIMENTAL

CKD-519 100mg or placebo

Drug: CKD-519; Drug: placebo

CKD-519 200mg

EXPERIMENTAL

CKD-519 200mg or placebo

Drug: CKD-519; Drug: placebo

Interventions

CKD-519 DRUG

CKD-519 100mg; CKD-519 200mg; CKD-519 50mg

placebo DRUG

CKD-519 100mg; CKD-519 200mg; CKD-519 50mg

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

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 Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Min-Su Park, Ph.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

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: April 25, 2016
• First Posted: April 28, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 13, 2017

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)