AnticoagulantPhase 1NCT04867200
A Clinical Study to Evaluate the Safety and Pharmacokinetics of CKD-344 in Healthy Volunteers
A Phase 1 study testing Lixiana(D006) and CKD-344 in people with Anticoagulant, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-344 Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anticoagulant
- What is being tested?
- Lixiana(D006) and CKD-344
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Apr 2021to 1 Jun 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers aged ≥ 19 years
- Weight ≥60kg, with calculated body mass index(BMI) of 18 to 30 kg/m2
- Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
- Those who are eligible for clinical trials based on laboratory (hematology, blood coagulation, blood chemistry, serology, urinalysis) at screening.
- Those who agree to contraception during the participation of clinical trial.
- Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
Who cannot join
- Those who has a medical evidence or a history of clinically significant gastrointestinal, cardiovascular, endocrine, pulmonary, hematological, infective disease, renal, urinary, psychiatric, neurologic, skeletomuscular, immune, etc.
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
- Those who had taken prescription or nonprescription drugs within 10 days prior to the first dose of investigational product.
- Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
- Those who donated whole blood within 8 weeks or blood components within 4 weeks prior to the first dose of the investigational product.
- Those who exceed an alcohol and cigarette consumption than below criteria. A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week B. Smoking: 20 cigarettes/day
Show all 11Show fewer
- Those who exceeds 2 times the upper limit of the reference range of AST(or ALT) or 1.5 times the upper limit of the reference range of γ-GTP.
- Those who have hypersensitivity to the drug or the drug ingredient, such as anaphylactic reactions.
- Those who have specific disease(e.g. severe bleeding disorder, severe renal/hepatic disease, uncontrolled severe hypertension, etc.)
- Those who were deemed inappropriate to participate in the study by the investigator.
- Those who have a pregnant or nursing woman.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
H+ Yangji Hospital
Seoul
Yook-HwanYook-Hwan Noh, +827046659174, yook.noh@gmail.com
About this study
Official title: An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-344 in Healthy Adult Volunteers
A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-344
Read the detailed description
A Phase 1 Clinical Trial to evaluate the safety and pharmacokinetics in healthy adult volunteers after administration of CKD-344.
- Conditions
- Anticoagulant
- Being tested
- Lixiana(D006), CKD-344
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lixiana(D006)Drug
Also called Reference Drug
NOAC(Factor Xa inhibitor)
CKD-344Drug
Also called Test Drug
NOAC(Factor Xa inhibitor)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 1. Period 1: Reference drug(Lixiana 60 mg)
2. Period 2: Test drug(CKD-344 60 mg) Receives: Drug: Lixiana(D006); Drug: CKD-344 |
| Group B | Experimental | 1. Period 1: Test drug(CKD-344 60 mg)
2. Period 2: Reference drug(Lixiana 60 mg) Receives: Drug: Lixiana(D006); Drug: CKD-344 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt(Area Under Curve last) of CKD-344
Area under the plasma concentration time curve of CKD-344, from time zero up to the last measurable concentration.
Measured: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Cmax
The maximum concentration observed of CKD-344 over blood sampling time.
Measured: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start27 Apr 2021
- Primary completion25 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulantStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yook-Hwan Noh, Principal investigator, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867200
- Sponsor's protocol ID
- A109_02BE2106
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-344 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04867200
- Acronym / sponsor ID
- A109_02BE2106
- Conditions
- Anticoagulant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 25 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 30 Apr 2021 (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 evaluate the Pharmacokinetics and safety of CKD-344
Detailed description
A Phase 1 Clinical Trial to evaluate the safety and pharmacokinetics in healthy adult volunteers after administration of CKD-344.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Lixiana(D006), Drug: CKD-3441. Period 1: Reference drug(Lixiana 60 mg) 2. Period 2: Test drug(CKD-344 60 mg) |
| Group B | Experimental | Drug: Lixiana(D006), Drug: CKD-3441. Period 1: Test drug(CKD-344 60 mg) 2. Period 2: Reference drug(Lixiana 60 mg) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adult volunteers aged ≥ 19 years
- Weight ≥60kg, with calculated body mass index(BMI) of 18 to 30 kg/m2
- Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
- Those who are eligible for clinical trials based on laboratory (hematology, blood coagulation, blood chemistry, serology, urinalysis) at screening.
- Those who agree to contraception during the participation of clinical trial.
Key exclusion criteria (11 listed)
- Those who has a medical evidence or a history of clinically significant gastrointestinal, cardiovascular, endocrine, pulmonary, hematological, infective disease, renal, urinary, psychiatric, neurologic, skeletomuscular, immune, etc.
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
- Those who had taken prescription or nonprescription drugs within 10 days prior to the first dose of investigational product.
- Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
- Those who donated whole blood within 8 weeks or blood components within 4 weeks prior to the first dose of the investigational product.
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 |
|---|---|---|
| Lixiana(D006)Also: Reference DrugNOAC(Factor Xa inhibitor) | Drug | Group A, Group B |
| CKD-344Also: Test DrugNOAC(Factor Xa inhibitor) | Drug | Group A, Group B |
Primary outcome
AUCt(Area Under Curve last) of CKD-344
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Area under the plasma concentration time curve of CKD-344, from time zero up to the last measurable concentration.
Cmax
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
The maximum concentration observed of CKD-344 over blood sampling time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
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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.
Yook-Hwan Noh principal investigator
South Korea
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 Lixiana(D006) and CKD-344 in people with Anticoagulant, 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 11 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: status not confirmed, as of the sponsor's last update on 30 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yook-Hwan Noh, M.D., PhD. (+82-70-4665-9174, yook.noh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt(Area Under Curve last) of CKD-344 (time frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 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 30 Apr 2021.