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

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

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: CKD-519; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seodaemun-gu
    • Seoul, Seodaemun-gu, Korea, Republic of, 120-752
      • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Between 19 aged and 55 aged in healthy adult
2. Body weight more than 55kg in male, 50kg in female
3. Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)

4. 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
5. 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
6. 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:

1. 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.
2. 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)
3. Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
4. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives.
5. 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.

6. 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

7. Defined by the following 12-lead ECG

   • HR<40 or >110bpm
   • PR interval>220ms or ≤110ms
   • QRS interval>120ms
   • QTcF<300ms or >450ms
   • Pathologic Q-waves (defined as >40ms or depth>0.5mV)
   • Incomplete or complete bundle branch block
   • Pre-excitation (e.g., Wolfe-Parkinson-White Syndrome)
   • Atrial fibrillation/flutter
   • Second- or third-degree atrioventricular (AV)block
   • Investigator judges to be unfavorable for consistently accurate QT measurements(e.g., indistinct QRS onset, low amplitude T wave, inverted or terminally inverted T wave, merged T/U waves, indistinct T wave offset , or prominent U wave that affects QT measurement)
8. Sitting SBP>150mmHg or <90mmHg, sitting DBP>100mmHg or <50mmHg, after 5 minutes break.
9. Drug abuse or have a history of drug abuse shows a positive for urine drug test.
10. Pregnant or lactating women.
11. A heavy caffeine consumer(caffeine>5 cups/day), alcohol consumer (alcohol>210g/week), or smoker(cigarette>10 cigarettes/day)
12. Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of subjects.
13. Subject who takes inhibitor and inducers of drug metabolizing enzyme (Barbiturates etc.) within 30 days.
14. Taking concomitant medications that prolong the QT/QTc interval within 14 days before the beginning of study treatment.
15. Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7days before the beginning of study treatment)
16. Subject who treated with any investigational drugs within 90 days before the beginning of study treatment
17. Previously donate whole blood within 60 days or component blood within 30 days.
18. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
19. Positive for Serology test(Hepatitis B, Hepatitis C, HIV)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CKD-519 400mg(PartⅠ: 1day); CKD-519 400mg(100mg x 4tabs) or placebo	Drug: CKD-519; Part 1 : CKD-519(100mg x 4 Tablets) for D1 Part 2 : CKD-519(100mg x 4 Tablets) for D1~D14; Drug: Placebo; Part 1 : CKD-519 placebo(100mg x 4 Tablets) for D1 Part 2 : CKD-519 placebo(100mg x 4 Tablets) for D1~D14
Experimental: CKD-519 400mg(PartⅡ: 14days); CKD-519 400mg(100mg x 4tabs) or placebo	Drug: CKD-519; Part 1 : CKD-519(100mg x 4 Tablets) for D1 Part 2 : CKD-519(100mg x 4 Tablets) for D1~D14; Drug: Placebo; Part 1 : CKD-519 placebo(100mg x 4 Tablets) for D1 Part 2 : CKD-519 placebo(100mg x 4 Tablets) for D1~D14

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamics(Lipid Parameter) of CKD-519	simultaneous with laboratory test after multiple administration	PartⅡ- Day1, Day3, Day7, Day10, Day12, Day14, Day15, Day16, Day17, Day21
Pharmacodynamics(CETP) of CKD-519	Pharmacodynamics after administration of single and multiple doses	Day1: 0(predose)~168hour
Pharmacodynamics(QC/QTc) of CKD-519	Pharmacokinetics after multiple administration	Part II - Day-1, Day 1, Day14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve [AUC] [Cmax] of CKD-519	Pharmacokinetics after administration of single and multiple	Part I - Day1: 0(predose)~168hour, Part II - Day1: 0(predose)~24hour, Day3~Day13:0(predose), Day14: 0(predose)~168hour

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2017
• Primary Completion (Actual): April 24, 2017
• Study Completion (Actual): April 24, 2017

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Dyslipidemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 148MAD16018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No