Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519

A Randomized, Open-label, Single Dose, 1-sequence, 3-treatment, 3-period Crossover Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519 in Healthy Male Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: CKD-519 200mg; Drug: CKD-519 100mg

Detailed Description

A randomized, open-label, single dose, 1-sequence, 3-treatment, 3-period crossover study to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519 in healthy male subjects.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Sungbuk-gu
    • Seoul, Sungbuk-gu, Korea, Republic of, 136-705
      • Korea University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Continuously taking caffeine(caffeine>5 cups/day), drinking alcohol(alcohol>210g/week), smoking excessive cigarettes(cigarette>10cigarettes/day)
• Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasons(for example, noncompliance, a disobliging manner)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CKD-519 tablet 100mg; 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; Other Names: CKD-519 soft capsule(formulation Ⅲ) 100mg(100mg X 1Cap)
Experimental: CKD-519 tablet 200mg; 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; Other Names: CKD-519 soft capsule(formulation Ⅲ) 200mg(100mg X 2Caps)
Experimental: CKD-519 soft capsule 100mg; 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; Other Names: CKD-519 soft capsule(formulation Ⅲ) 100mg(100mg X 1Cap)
Experimental: CKD-519 soft capsule 200mg; 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; Other Names: CKD-519 soft capsule(formulation Ⅲ) 200mg(100mg X 2Caps)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Inhibition of CETP(Cholesteryl ester transfer protein) Activity	0(predose)~168

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Ji Young Park, MD, PhD, Korea University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 21, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Dyslipidemia; CKD-519; CETP inhibitor; Food Drug Interaction
• Other Study ID Numbers: 148FDI16004

Plan for Individual participant data (IPD)

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