Study to Investigate the Influence of CKD-519 on 24-h Ambulatory Blood Pressure in Healthy Adult Volunteers

A Randomized, Double-blind, Placebo-controlled, Multiple Dosing, Cross-over Phase I Clinical Trial to Investigate the Effect of CKD-519 on 24-h Ambulatory Blood Pressure After Oral Administration in Healthy Adult Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: CKD-519 200mg

Detailed Description

A randomized, double-blind, placebo-controlled, multiple dosing, cross-over phase I clinical trial to investigate the effect of CKD-519 on 24-h ambulatory blood pressure after oral administration in healthy adult volunteers.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• 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 gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives.
4. 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.

5. 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
6. Sitting SBP > 140mmHg or < 90mmHg, sitting DBP > 90mmHg or < 60mmHg, after 5 minutes break.
7. The difference in DBP>10mmHg or SBP >20mmHg at the screening period
8. Drug abuse or have a history of drug abuse shows a positive for urine drug test.
9. Pregnant or lactating women.
10. A heavy caffeine consumer(caffeine>5 cups/day), alcohol consumer(alcohol>210g/week),
11. smoker(except the one who have stopped smoking more than 90days before beginning of study treatment)
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 foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days before the beginning of study treatment)
15. Subject who treated with any investigational drugs within 90 days before the beginning of study treatment
16. Previously donate whole blood within 60 days or component blood within 30 days.
17. Positive for Serology test(Hepatitis B, Hepatitis C, HIV)
18. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; placebo	Drug: Placebo
EXPERIMENTAL: CKD-519 200mg; CKD-519 tab(formulation II) 200mg (100mg X 2tabs)	Drug: CKD-519 200mg; Other Names: (formulation II) 200mg (100mg X 2tabs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Min Soo Park, MD, PhD, Severance Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 27, 2016
• First Posted (ESTIMATE): September 28, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Dyslipidemia; ABPM; CKD-519; CETP inhibitor
• Other Study ID Numbers: 148HPS16006

Plan for Individual participant data (IPD)

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