Study to Evaluate the Drug Interaction Between CKD-519 and Rosuvastatin in Healthy Male Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects.

Detailed Description
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An open-label, multiple dose, fixed-sequence, 3-period study to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects.

Official Title
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An Open-label, Multiple Dose, Fixed-sequence, 3-period Study to Evaluate the Drug Interaction Between CKD-519 and Rosuvastatin in Healthy Male Subjects

Conditions
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Dyslipidemias

Intervention / Treatment
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* Drug: Rosuvastatin 20 mg
* Drug: CKD-519 200 mg
* Drug: Rosuvastatin 20 mg & CKD-519 200 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers aged between ≥ 20 and ≤ 45 years old Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m² Subjects to consents to use effective birth controls for at least 2 months following the last dose Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written Exclusion Criteria: History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration Any medical history that may affect drug absorption, distribution, metabolism and excretion Any hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of statin-related medication or Cholesteryl Ester Transfer Protein(CETP) inhibitor or other drugs(aspirin, antibiotics) Continuous cryptogenic elevation of serum transaminase or active liver disease including elevation of serum transaminase > 3 fold upper normal limit(UNL) Severe renal failure(creatinin clearance < 30 ml/min) Hypothyroidism or clinically significant test result Galactose intolerance, Lapp lactose intolerance, glucose-galactose malabsorption or genetic disorders Any clinically significant chronic medical illness Any clinically significant hypotension or hypertension (systolic < 100 mmHg/diastolic < 60 mmHg or systolic > 140 mmHg /diastolic > 90 mmHg) Corrected QT interval(QTc) >450msec on 12-lead ECG Positive blood tests for hemoglobins(HBs) Ag, anti-hepatitis C virus(HCV) Ab, anti-HIV Ab, or venereal disease research laboratory(VDRL) Creatine phosphokinase(CPK) ≥ 5 fold of upper normal limit(UNL) Use of any prescription drugs within 14 days prior to study drug administration Use of any other drugs, including over-the-counter medications and herbal preparations within 7 days prior to study drug administration History of clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not require any treatment may be allowed) Inability to take normal hospital diet Donation of blood within 60 days prior to study drug administration or plasma to a blood bank within 20 days prior to study drug administration Blood transfusion within 30 days prior to study drug administration Exposure to any investigational drug or placebo within 90 days prior to the first Investigational Product(IP) administration Subjects taking any drugs to induce or inhibit drug metabolizing enzymes including barbiturates within 30 days prior to the first Investigational Product(IP) administration Subjects with excessive caffeine intake (more than 5 cups/day), heavy smoking (more than 10 cigarettes/day), regular alcohol intake (more than 210 g/week) Subjects having been deemed inappropriate for the trial as determined by the investigator

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin 20 mg & CKD-519 200 mg<br>Period 1: Treatment A(Rosuvastatin 20 mg(20 mg X 1 tablet)) Period 2: Treatment B(CKD-519 200 mg(100 mg X 2 tablets)) Period 3: Treatment C(Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets)) | Drug: Rosuvastatin 20 mg<br>* Treatment A: Rosuvastatin 20 mg(20 mg X 1 tablet) for Day1 Day5<br>* Other names: Rosuvastatin 20 mg(20 mg X 1 tablet);Drug: CKD-519 200 mg<br>* Treatment B: CKD-519 200 mg(100 mg X 2 tablets) for Day9 Day21<br>* Other names: CKD-519 200 mg(100 mg X 2 tablets);Drug: Rosuvastatin 20 mg & CKD-519 200 mg<br>* Treatment C: Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets) for Day22 Day26<br>* Other names: Rosuvastatin 20 mg(20 mgX1 tablet), CKD-519 200 mg(100 mgX2 tablets);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Area under the plasma concentration versus time curve (AUCτ)) | At steady state after multiple administration of CKD-519, Rosuvastatin | 0(predose) 24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Peak plasma Concentration (Cmax,ss)) | At steady state after multiple administration of CKD-519, Rosuvastatin | 0(predose) 24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26 | 
| Pharmacokinetics (Minimum plasma Concentration (Cmin,ss)) | At steady state after multiple administration of CKD-519, Rosuvastatin | 0(predose) 24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26 | 
| Pharmacokinetics (Time to maximum plasma concentration (Tmax,ss)) | At steady state after multiple administration of CKD-519, Rosuvastatin | 0(predose) 24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26 | 
| Pharmacokinetics (t1/2) | At steady state after multiple administration of CKD-519, Rosuvastatin | 0(predose) 24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26 | 
| Pharmacodynamics (CETP activity) | At steady state after multiple administration of CKD-519, Rosuvastatin | 0(predose) 24 hours at Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26 | 
| Pharmacodynamics (CETP Concentration) | At steady state after multiple administration of CKD-519, Rosuvastatin | 0(predose) 24 hours at Day9, Day19, Day22, Day26 | 
| Pharmacodynamics (Lipid profiles) |  | simultaneous with laboratory test at Day1, Day6, Day9, Day20, Day22, Day27 | 

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