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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: CKD-519 100mg
* Drug: CKD-519 200mg
* Drug: CKD-519 100mg
* Drug: CKD-519 200mg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-519 tablet 100mg<br>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<br> <br> * Other names: CKD-519 tablet(formulation Ⅱ) 100mg(100mg X 1Tab);|
| Experimental: CKD-519 tablet 200mg<br>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<br> <br> * Other names: CKD-519 tablet(formulation Ⅱ) 200mg(100mg X 2Tabs);|
| Experimental: CKD-519 soft capsule 100mg<br>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<br> <br> * Other names: CKD-519 soft capsule(formulation Ⅲ) 100mg(100mg X 1Cap);|
| Experimental: CKD-519 soft capsule 200mg<br>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<br> <br> * Other names: CKD-519 soft capsule(formulation Ⅲ) 200mg(100mg X 2Caps);|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, CKD-519, CETP inhibitor, Food Drug Interaction