DyslipidemiasPhase 1NCT05634447
A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391
A Phase 1 study testing Drug: CKD-391, QD, PO in people with Dyslipidemias, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-391 Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Drug: CKD-391, QD, PO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Dec 2022to 7 Jun 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult aged between 19 to 55 at screening
- Weight ≥ 50kg(man) or 45kg(woman), with calculated body mass index (BMI) of 18 to 30kg/m2
- Those who have no clinically significant congenital or chronic diseases and have no abnormal symptoms of findings
- Those who are deemed suitable for clinical trials based on laboratory (hematology, blood chemistry, serology, urinalysis, urine drug test) and 12-lead ECG results at screening
- Those who agree to contraception from the first IP dosing day till 14 days after the last dosing day and decide not to provide sperm during the participation of clinical trial
- Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial
Who cannot join
- Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day
- Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 21 glasses/week(man), 14 glasses/week(woman), smoking> 20 cigarettes/day) and not able to stop on smoking, caffeine and alcohol
- Those who received investigational products or participated in bioequivalence test within 6 months before the first administration of clinical trial drugs
- Those who donated whole blood within 8 weeks before the first date of administration and donated ingredients within 2 weeks or received blood transfusion in 4 weeks
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery
- Patients with the following diseases
Show all 17Show fewer
- Patients with active liver disease or with elevated amino transferase levels with unknown cause increased by more than 3 times the normal upper limit
- Patients with severe liver failure or biliary obstruction and bile congestion
- Patients with muscular disease, rhabdomyolysis, or persons with a past history
- Patients with hypothyroidism, patients with genetic muscle disease or their family history, and patients with history of muscle disability due to drugs
- Patients with renal impairment or a history of in and patients with severe renal dysfunction
- Patients with a history of muscle toxicity to other statin drugs or fibrate drugs
- Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Those who have hypersensitivity to the main constituents or components of the investigational drug
- Those who have a history of drug abuse within 1 year of screening or who have tested positive for urine drug tests
- Woman who are pregnant or breastfeeding
- Those who are deemed insufficient to participate in clinical study by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-391 and Co-administration of CKD-331 and D337 in Healthy Adult Volunteers
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-391
Read the detailed description
A phase I clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after administration of CKD-391 and co-administration of CKD-331 and D337 in healthy adult volunteers
- Conditions
- Dyslipidemias
- Being tested
- Drug: CKD-391, QD, PO
- Keywords
- CKD-391
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: CKD-391, QD, PODrug
Drug: CKD-331, D337 QD, PO
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | * Period 1: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
* Period 2: CKD-391 - A single oral dose of 1 tablet under fasting condition
* Period 3: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
* Period 4: CKD-391 - A single oral dose of 1 tablet under fasting condition Receives: Drug: Drug: CKD-391, QD, PO |
| Sequence 2 | Experimental | * Period 1: CKD-391 - A single oral dose of 1 tablet under fasting condition
* Period 2: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
* Period 3: CKD-391 - A single oral dose of 1 tablet under fasting condition
* Period 4: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition Receives: Drug: Drug: CKD-391, QD, PO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
AUCt of CKD-391: Area under the concentration-time curve time zero to time
Measured: Pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hours
Primary Outcome Measure
Cmax of CKD-391: Maximum plasma concentration of the drug
Measured: Pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start20 Dec 2022
- Primary completion27 Feb 2023
- Study completion7 Jun 2023
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.
- 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
- 69 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
- NCT05634447
- Sponsor's protocol ID
- A52_10BE2220
- Status last verified
- Nov 2022
- First submitted
- 22 Nov 2022
- Last updated
- 6 Oct 2023
- Results posted
- 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 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-391 and Co-administration of CKD-331 and D337 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05634447
- Acronym / sponsor ID
- A52_10BE2220
- Conditions
- Dyslipidemias
- Keywords
- CKD-391
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 2 Dec 2022 (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.
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-391
Detailed description
A phase I clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after administration of CKD-391 and co-administration of CKD-331 and D337 in healthy adult volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Drug: CKD-391, QD, PO* Period 1: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition * Period 2: CKD-391 - A single oral dose of 1 tablet under fasting condition * Period 3: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition * Period 4: CKD-391 - A single oral dose of 1 tablet under fasting condition |
| Sequence 2 | Experimental | Drug: Drug: CKD-391, QD, PO* Period 1: CKD-391 - A single oral dose of 1 tablet under fasting condition * Period 2: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition * Period 3: CKD-391 - A single oral dose of 1 tablet under fasting condition * Period 4: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult aged between 19 to 55 at screening
- Weight ≥ 50kg(man) or 45kg(woman), with calculated body mass index (BMI) of 18 to 30kg/m2
- Those who have no clinically significant congenital or chronic diseases and have no abnormal symptoms of findings
- Those who are deemed suitable for clinical trials based on laboratory (hematology, blood chemistry, serology, urinalysis, urine drug test) and 12-lead ECG results at screening
- Those who agree to contraception from the first IP dosing day till 14 days after the last dosing day and decide not to provide sperm during the participation of clinical trial
Key exclusion criteria (17 listed)
- Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day
- Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 21 glasses/week(man), 14 glasses/week(woman), smoking> 20 cigarettes/day) and not able to stop on smoking, caffeine and alcohol
- Those who received investigational products or participated in bioequivalence test within 6 months before the first administration of clinical trial drugs
- Those who donated whole blood within 8 weeks before the first date of administration and donated ingredients within 2 weeks or received blood transfusion in 4 weeks
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery
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 |
|---|---|---|
| Drug: CKD-391, QD, PODrug: CKD-331, D337 QD, PO | Drug | Sequence 1, Sequence 2 |
Primary outcome
Primary Outcome Measure
Time frame: Pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hours
AUCt of CKD-391: Area under the concentration-time curve time zero to time
Primary Outcome Measure
Time frame: Pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hours
Cmax of CKD-391: Maximum plasma concentration of the drug
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 6 Oct 2023.
- 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.
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 Drug: CKD-391, QD, PO 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 6 inclusion and 17 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 6 Oct 2023. 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?
Primary Outcome Measure (time frame: Pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hours). 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 6 Oct 2023.