DyslipidemiasPhase 1NCT03175835
Study to Evaluate the Drug Interaction Between CKD-519 and Rosuvastatin in Healthy Male Subjects
A Phase 1 study testing Rosuvastatin 20 mg, CKD-519 200 mg and Rosuvastatin 20 mg & CKD-519 200 mg in people with Dyslipidemias, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Rosuvastatin 20 mg, CKD-519 200 mg and Rosuvastatin 20 mg & CKD-519 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 May 2017to 19 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects.
Read the 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.
- Conditions
- Dyslipidemias
- Being tested
- Rosuvastatin 20 mg, CKD-519 200 mg, Rosuvastatin 20 mg & CKD-519 200 mg
- Keywords
- Dyslipidemia, CKD-519, Rosuvastatin, Drug-Drug Interaction
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 20 mgDrug
Also called Rosuvastatin 20 mg(20 mg X 1 tablet)
Treatment A: Rosuvastatin 20 mg(20 mg X 1 tablet) for Day1~Day5
CKD-519 200 mgDrug
Also called CKD-519 200 mg(100 mg X 2 tablets)
Treatment B: CKD-519 200 mg(100 mg X 2 tablets) for Day9~Day21
Rosuvastatin 20 mg & CKD-519 200 mgDrug
Also called Rosuvastatin 20 mg(20 mgX1 tablet), CKD-519 200 mg(100 mgX2 tablets)
Treatment C: Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets) for Day22~Day26
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 20 mg & CKD-519 200 mg | Experimental | 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)) Receives: Drug: Rosuvastatin 20 mg; Drug: CKD-519 200 mg; Drug: Rosuvastatin 20 mg & CKD-519 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (Area under the plasma concentration versus time curve (AUCτ))
At steady state after multiple administration of CKD-519, Rosuvastatin
Measured: 0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26
Secondary outcomes (7)
Pharmacokinetics (Peak plasma Concentration (Cmax,ss))
At steady state after multiple administration of CKD-519, Rosuvastatin
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0(predose)~24 hours at Day9, Day19, Day22, Day26
Pharmacodynamics (Lipid profiles)
Measured: simultaneous with laboratory test at Day1, Day6, Day9, Day20, Day22, Day27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start8 May 2017
- Primary completion19 Jun 2017
- Study completion19 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175835
- Sponsor's protocol ID
- 148DDI16023
- Status last verified
- Apr 2017
- First submitted
- 18 May 2017
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03175835
- Acronym / sponsor ID
- 148DDI16023
- Conditions
- Dyslipidemias
- Keywords
- Dyslipidemia, CKD-519, Rosuvastatin, Drug-Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin 20 mg & CKD-519 200 mg | Experimental | Drug: Rosuvastatin 20 mg, Drug: CKD-519 200 mg, Drug: Rosuvastatin 20 mg & CKD-519 200 mgPeriod 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)) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin 20 mgAlso: Rosuvastatin 20 mg(20 mg X 1 tablet)Treatment A: Rosuvastatin 20 mg(20 mg X 1 tablet) for Day1~Day5 | Drug | Rosuvastatin 20 mg & CKD-519 200 mg |
| CKD-519 200 mgAlso: CKD-519 200 mg(100 mg X 2 tablets)Treatment B: CKD-519 200 mg(100 mg X 2 tablets) for Day9~Day21 | Drug | Rosuvastatin 20 mg & CKD-519 200 mg |
| Rosuvastatin 20 mg & CKD-519 200 mgAlso: Rosuvastatin 20 mg(20 mgX1 tablet), CKD-519 200 mg(100 mgX2 tablets)Treatment C: Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets) for Day22~Day26 | Drug | Rosuvastatin 20 mg & CKD-519 200 mg |
Primary outcome
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
7 secondary outcomes
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
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
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
Pharmacokinetics (t1/2)
Time frame: 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
Pharmacodynamics (CETP Concentration)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Dyslipidemias
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruitingPhase 2
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Diabetes, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rosuvastatin 20 mg, CKD-519 200 mg and Rosuvastatin 20 mg & CKD-519 200 mg in people with Dyslipidemias, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.