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

Phase 1

Completed

• Conditions: Dyslipidemias
• Interventions: Drug: Rosuvastatin 20 mg; Drug: CKD-519 200 mg; Drug: Rosuvastatin 20 mg & CKD-519 200 mg

• Registration Number: NCT03175835
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

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 Timeline

• Status Verified: 2017-04
• Study Start: 2017-05-08
• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Primary Completion: 2017-06-19
• Study Completion: 2017-06-19
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rosuvastatin 20 mg & CKD-519 200 mg	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))
Rosuvastatin 20 mg & CKD-519 200 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))
Rosuvastatin 20 mg & CKD-519 200 mg	Rosuvastatin 20 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))

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of