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

July 5, 2017 updated by: Chong Kun Dang Pharmaceutical

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (Area under the plasma concentration versus time curve (AUCτ))
Time Frame: 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
0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (Peak plasma Concentration (Cmax,ss))
Time Frame: 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
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))
Time Frame: 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
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))
Time Frame: 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
0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26
Pharmacokinetics (t1/2)
Time Frame: 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
0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26
Pharmacodynamics (CETP activity)
Time Frame: 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
0(predose)~24 hours at Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26
Pharmacodynamics (CETP Concentration)
Time Frame: 0(predose)~24 hours at Day9, Day19, Day22, Day26
At steady state after multiple administration of CKD-519, Rosuvastatin
0(predose)~24 hours at Day9, Day19, Day22, Day26
Pharmacodynamics (Lipid profiles)
Time Frame: simultaneous with laboratory test at Day1, Day6, Day9, Day20, Day22, Day27
simultaneous with laboratory test at Day1, Day6, Day9, Day20, Day22, Day27

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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