DyslipidemiaPhase 1CKD-519 FIHNCT02156544
Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519
A Phase 1 study testing CKD-519 in people with Dyslipidemia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- CKD-519
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 19 aged and 55 aged in healthy adult
- Body weight more than 55kg in male, 50kg in female
- Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
- If female, must include more than one among the items
- The menopause(there is no natural menses for at least 2 years)
- Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition
- If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
- Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent
Who cannot join
- Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system(heart failure, etc) or mental illness, or a history of mental disease.
- Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives.
- An impossible one who participates in clinical trial including screening tests(medical history taking, BP, 12-lead ECG, physical examination, blood\&urine laboratory test result) before 28 days the taking investigational Products.
- Defined by the following laboratory parameters
- AST, ALT>1.25* upper limit of normal range
Show all 20Show fewer
- Total bilirubin>1.5* upper limit of normal range
- CPK>1.5* upper limit of normal range
- eGFR(using by MDRD method)<60mL/min/1.73m2
- Sitting SBP>150mmHg or <90mmHg, sitting DBP>100mmHg or <50mmHg, after 5 minutes break.
- Drug abuse or have a history of drug abuse showes a positive for urine drug test.
- Pregnant or lactating women.
- A heavy caffeine consumer(caffeine>5 cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10 cigarettes/day)
- Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of subjects.
- Subject who takes inhibitor and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days.
- Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days before the beginning of study treatment)
- Subject who treated with any investigational drugs within 60 days before the beginning of study treatment(However, biologicals applies for 90 days, but can be based on a more extended period of time by considering the half-life)
- Previously donate whole blood within 60 days or component blood within 30 days.
- An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
- Positive for Serology test(Hepatitis B, Hepatitis C, HIV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose-block Randomized, Double-blind, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519 After Oral Administration in Healthy Adult Volunteers
The purpose of this study is to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519.
- Conditions
- Dyslipidemia
- Being tested
- CKD-519, placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-519Drug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| CKD-519 25mg | Experimental | CKD-519 25mg or placebo Receives: Drug: CKD-519; Drug: placebo |
| CKD-519 50mg | Experimental | CKD-519 50mg or placebo Receives: Drug: CKD-519; Drug: placebo |
| CKD-519 100mg | Experimental | CKD-519 100mg or placebo Receives: Drug: CKD-519; Drug: placebo |
| CKD-519 200mg | Experimental | CKD-519 200mg or placebo Receives: Drug: CKD-519; Drug: placebo |
| CKD-519 400mg | Experimental | CKD-519 400mg or placebo Receives: Drug: CKD-519; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of CKD-519
Measured: 0(predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
AUC0-last of CKD-519
Measured: 0(predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
AUC0-∞ of CKD-519
Measured: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
Tmax of CKD-519
Measured: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
t1/2 of CKD-519
Measured: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
CL/F of CKD-519
Measured: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
Vd/F of CKD-519
Measured: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
Secondary outcomes (1)
CETP activity
Measured: 0(Predose), 0.5, 1, 2, 4, 8, 18, 24, 48, 72, 96, 120, 144, 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Su Park, Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156544
- Sponsor's protocol ID
- 148HPS14001
- Acronym
- CKD-519 FIH
- Status last verified
- May 2014
- First submitted
- 1 Jun 2014
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-block Randomized, Double-blind, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519 After Oral Administration in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02156544
- Acronym / sponsor ID
- CKD-519 FIH / 148HPS14001
- Conditions
- Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Jun 2014 (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.
The purpose of this study is to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CKD-519 25mg | Experimental | Drug: CKD-519, Drug: placeboCKD-519 25mg or placebo |
| CKD-519 50mg | Experimental | Drug: CKD-519, Drug: placeboCKD-519 50mg or placebo |
| CKD-519 100mg | Experimental | Drug: CKD-519, Drug: placeboCKD-519 100mg or placebo |
| CKD-519 200mg | Experimental | Drug: CKD-519, Drug: placeboCKD-519 200mg or placebo |
| CKD-519 400mg | Experimental | Drug: CKD-519, Drug: placeboCKD-519 400mg or placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Between 19 aged and 55 aged in healthy adult
- Body weight more than 55kg in male, 50kg in female
- Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
- If female, must include more than one among the items
- If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
Key exclusion criteria (20 listed)
- Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system(heart failure, etc) or mental illness, or a history of mental disease.
- Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives.
- An impossible one who participates in clinical trial including screening tests(medical history taking, BP, 12-lead ECG, physical examination, blood\&urine laboratory test result) before 28 days the taking investigational Products.
- Defined by the following laboratory parameters
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-519 | Drug | CKD-519 100mg, CKD-519 200mg, CKD-519 25mg, CKD-519 400mg, CKD-519 50mg |
| placebo | Drug | CKD-519 100mg, CKD-519 200mg, CKD-519 25mg, CKD-519 400mg, CKD-519 50mg |
Primary outcome
Cmax of CKD-519
Time frame: 0(predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
AUC0-last of CKD-519
Time frame: 0(predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
AUC0-∞ of CKD-519
Time frame: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
Tmax of CKD-519
Time frame: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
t1/2 of CKD-519
Time frame: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
CL/F of CKD-519
Time frame: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
Vd/F of CKD-519
Time frame: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
1 secondary outcome
CETP activity
Time frame: 0(Predose), 0.5, 1, 2, 4, 8, 18, 24, 48, 72, 96, 120, 144, 168
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 11 Sep 2015.
Related trials for Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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.
Min-Su Park, Ph.D principal investigator
Severance Hospital
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 CKD-519 in people with Dyslipidemia, 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 8 inclusion and 20 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 11 Sep 2015. 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?
Cmax of CKD-519 (time frame: 0(predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168). The study lists 7 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 11 Sep 2015.