HealthyPhase 1NCT02501200
CKD-391 Pharmacokinetic Study Phase I
A Phase 1 study testing CKD-391 and Atrovastatin and Ezetimibe combination therapy in people with Healthy, run by Chong Kun Dang Pharmaceutical.
Trial summary
A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CKD-391 and Atrovastatin and Ezetimibe combination therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 2015
- 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Bwt >=50kg, BMI 18.5~25
- signed the informed consent form prior to the study participation
Who cannot join
- - Clinically significant disease
- Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
- Clinically significant allergic disease
- Impossible to taking the institutional standard meal
- Previously donate whole blood within 60 days or component blood within 20 days
- Previously participated in other trial within 90 days
- Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
- An impossible one who participates in clinical trial by investigator's decision including laboratory test result
About this study
Official title: Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of CKD-391 in Healthy Male Subjects
A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.
Read the detailed description
To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial.
Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.
- Conditions
- Healthy
- Being tested
- CKD-391, Atrovastatin and Ezetimibe combination therapy
- Keywords
- Dyslipidemia, CKD-391, Atorvastatin, Ezetimibe
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-391Drug
Investigational product is prescribed to all of randomized subjects for two times.
Atrovastatin and Ezetimibe combination therapyDrug
Investigational products are prescribed to all of radomized subjects for two times.
| Study group | Role | What they receive |
|---|---|---|
| TR group | Experimental | CKD-391 and combination dose of Atrovastatin and Ezetimibe in order Receives: Drug: CKD-391; Drug: Atrovastatin and Ezetimibe combination therapy |
| RT group | Experimental | combination dose of Atrovastatin and Ezetimibe and CKD-391 in order Receives: Drug: CKD-391; Drug: Atrovastatin and Ezetimibe combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
Measured: up to 96 hours post dose
Cmax
Measured: up to 96 hours post dose
Secondary outcomes (4)
Tmax
Measured: up to 96 hours post dose
T1/2
Measured: up to 96 hours post dose
AUCinf
Measured: up to 96 hours post dose
Adverse events
Measured: up to 24days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Choon Ok Kim, Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501200
- Sponsor's protocol ID
- 152BE15026
- Status last verified
- Oct 2015
- First submitted
- 16 Jul 2015
- Last updated
- 26 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of CKD-391 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02501200
- Acronym / sponsor ID
- 152BE15026
- Conditions
- Healthy
- Keywords
- Dyslipidemia, CKD-391, Atorvastatin, Ezetimibe
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Jul 2015 (estimated)
- 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.
A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.
Detailed description
To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial.
Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TR group | Experimental | Drug: CKD-391, Drug: Atrovastatin and Ezetimibe combination therapyCKD-391 and combination dose of Atrovastatin and Ezetimibe in order |
| RT group | Experimental | Drug: CKD-391, Drug: Atrovastatin and Ezetimibe combination therapycombination dose of Atrovastatin and Ezetimibe and CKD-391 in order |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Bwt >=50kg, BMI 18.5~25
- signed the informed consent form prior to the study participation
Key exclusion criteria (8 listed)
- - Clinically significant disease
- Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
- Clinically significant allergic disease
- Impossible to taking the institutional standard meal
- Previously donate whole blood within 60 days or component blood within 20 days
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 |
|---|---|---|
| CKD-391Investigational product is prescribed to all of randomized subjects for two times. | Drug | RT group, TR group |
| Atrovastatin and Ezetimibe combination therapyInvestigational products are prescribed to all of radomized subjects for two times. | Drug | RT group, TR group |
Primary outcome
AUClast
Time frame: up to 96 hours post dose
Cmax
Time frame: up to 96 hours post dose
4 secondary outcomes
Tmax
Time frame: up to 96 hours post dose
T1/2
Time frame: up to 96 hours post dose
AUCinf
Time frame: up to 96 hours post dose
Adverse events
Time frame: up to 24days post dose
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 26 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Choon Ok Kim, Ph.D principal investigator
Severance Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-391 and Atrovastatin and Ezetimibe combination therapy in people with Healthy, run by Chong Kun Dang Pharmaceutical.
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 2 inclusion and 8 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 26 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
AUClast (time frame: up to 96 hours post dose). The study lists 2 primary outcomes in all. 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 26 Dec 2016.