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

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

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemias
• Intervention / Treatment: Drug: Rosuvastatin 20 mg; Drug: CKD-519 200 mg; Drug: Rosuvastatin 20 mg & CKD-519 200 mg

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital

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:

1. Healthy volunteers aged between ≥ 20 and ≤ 45 years old
2. Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
3. Subjects to consents to use effective birth controls for at least 2 months following the last dose
4. 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:

1. History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder
2. With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
3. Any medical history that may affect drug absorption, distribution, metabolism and excretion
4. 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)
5. Continuous cryptogenic elevation of serum transaminase or active liver disease including elevation of serum transaminase > 3 fold upper normal limit(UNL)
6. Severe renal failure(creatinin clearance < 30 ml/min)
7. Hypothyroidism or clinically significant test result
8. Galactose intolerance, Lapp lactose intolerance, glucose-galactose malabsorption or genetic disorders
9. Any clinically significant chronic medical illness
10. Any clinically significant hypotension or hypertension (systolic < 100 mmHg/diastolic < 60 mmHg or systolic > 140 mmHg /diastolic > 90 mmHg)
11. Corrected QT interval(QTc) >450msec on 12-lead ECG
12. Positive blood tests for hemoglobins(HBs) Ag, anti-hepatitis C virus(HCV) Ab, anti-HIV Ab, or venereal disease research laboratory(VDRL)
13. Creatine phosphokinase(CPK) ≥ 5 fold of upper normal limit(UNL)
14. Use of any prescription drugs within 14 days prior to study drug administration
15. Use of any other drugs, including over-the-counter medications and herbal preparations within 7 days prior to study drug administration
16. History of clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not require any treatment may be allowed)
17. Inability to take normal hospital diet
18. 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
19. Blood transfusion within 30 days prior to study drug administration
20. Exposure to any investigational drug or placebo within 90 days prior to the first Investigational Product(IP) administration
21. Subjects taking any drugs to induce or inhibit drug metabolizing enzymes including barbiturates within 30 days prior to the first Investigational Product(IP) administration
22. 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)
23. Subjects having been deemed inappropriate for the trial as determined by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Rosuvastatin 20 mg & CKD-519 200 mg; 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; Treatment A: Rosuvastatin 20 mg(20 mg X 1 tablet) for Day1~Day5; Other Names: Rosuvastatin 20 mg(20 mg X 1 tablet); Drug: CKD-519 200 mg; Treatment B: CKD-519 200 mg(100 mg X 2 tablets) for Day9~Day21; Other Names: CKD-519 200 mg(100 mg X 2 tablets); Drug: Rosuvastatin 20 mg & CKD-519 200 mg; Treatment C: Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets) for Day22~Day26; Other Names: Rosuvastatin 20 mg(20 mgX1 tablet), CKD-519 200 mg(100 mgX2 tablets)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): June 19, 2017
• Study Completion (Actual): June 19, 2017

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Dyslipidemia; Rosuvastatin; Drug-Drug Interaction; CKD-519
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: 148DDI16023

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