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

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175835
• Other study ID #: 148DDI16023
• Status: Completed
• Phase: Phase 1
• First received: May 18, 2017
• Last updated: July 5, 2017
• Start date: May 8, 2017
• Est. completion date: June 19, 2017

Study information

• Verified date: April 2017
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 19, 2017
• Est. primary completion date: June 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• Rosuvastatin 20 mg
Treatment A: Rosuvastatin 20 mg(20 mg X 1 tablet) for Day1~Day5
• CKD-519 200 mg
Treatment B: CKD-519 200 mg(100 mg X 2 tablets) for Day9~Day21
• 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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (Area under the plasma concentration versus time curve (AUCt))	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pharmacodynamics (CETP Concentration)	At steady state after multiple administration of CKD-519, Rosuvastatin	0(predose)~24 hours at Day9, Day19, Day22, Day26
Secondary	Pharmacodynamics (Lipid profiles)		simultaneous with laboratory test at Day1, Day6, Day9, Day20, Day22, Day27