Healthy VolunteersPhase 1NCT02916901
Study to Investigate the Influence of CKD-519 on 24-h Ambulatory Blood Pressure in Healthy Adult Volunteers
A Phase 1 study testing CKD-519 200mg in people with Healthy Volunteers, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to determine influence of CKD-519 on 24-h ambulatory blood pressure after oral administration in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CKD-519 200mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Jan 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 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 22Show 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 > 140mmHg or < 90mmHg, sitting DBP > 90mmHg or < 60mmHg, after 5 minutes break.
- The difference in DBP>10mmHg or SBP >20mmHg at the screening period
- Drug abuse or have a history of drug abuse shows a positive for urine drug test.
- Pregnant or lactating women.
- A heavy caffeine consumer(caffeine>5 cups/day), alcohol consumer(alcohol>210g/week),
- smoker(except the one who have stopped smoking more than 90days before beginning of study treatment)
- 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 90 days before the beginning of study treatment
- Previously donate whole blood within 60 days or component blood within 30 days.
- Positive for Serology test(Hepatitis B, Hepatitis C, HIV)
- An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Dosing, Cross-over Phase I Clinical Trial to Investigate the Effect of CKD-519 on 24-h Ambulatory Blood Pressure After Oral Administration in Healthy Adult Volunteers
The purpose of this study is to determine influence of CKD-519 on 24-h ambulatory blood pressure after oral administration in healthy adult volunteers.
Read the detailed description
A randomized, double-blind, placebo-controlled, multiple dosing, cross-over phase I clinical trial to investigate the effect of CKD-519 on 24-h ambulatory blood pressure after oral administration in healthy adult volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- CKD-519 200mg, Placebo
- Keywords
- Dyslipidemia, CKD-519, CETP inhibitor, ABPM
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-519 200mgDrug
Also called (formulation II) 200mg (100mg X 2tabs)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CKD-519 200mg | Experimental | CKD-519 tab(formulation II) 200mg (100mg X 2tabs) Receives: Drug: CKD-519 200mg |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24h average SBP and DBP from baseline to Day 14 Each time point is as following: Daytime: 06:00~21:59 Nighttime: 22:00~05:59
Measured: 14days
Secondary outcomes (3)
Cmax,ss of CKD-519
Measured: 0(predose)~24 at day15
AUCτ,ss of CKD-519
Measured: 0(predose)~24 at day15
Tmax,ss of CKD-519
Measured: 0(predose)~24 at day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Soo Park, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916901
- Sponsor's protocol ID
- 148HPS16006
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2016
- Last updated
- 23 Feb 2017
- 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 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Dosing, Cross-over Phase I Clinical Trial to Investigate the Effect of CKD-519 on 24-h Ambulatory Blood Pressure After Oral Administration in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02916901
- Acronym / sponsor ID
- 148HPS16006
- Conditions
- Healthy Volunteers
- Keywords
- Dyslipidemia, CKD-519, CETP inhibitor, ABPM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 28 Sep 2016 (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 determine influence of CKD-519 on 24-h ambulatory blood pressure after oral administration in healthy adult volunteers.
Detailed description
A randomized, double-blind, placebo-controlled, multiple dosing, cross-over phase I clinical trial to investigate the effect of CKD-519 on 24-h ambulatory blood pressure after oral administration in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD-519 200mg | Experimental | Drug: CKD-519 200mgCKD-519 tab(formulation II) 200mg (100mg X 2tabs) |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
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 (22 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 200mgAlso: (formulation II) 200mg (100mg X 2tabs) | Drug | CKD-519 200mg |
| Placebo | Drug | Placebo |
Primary outcome
Change in 24h average SBP and DBP from baseline to Day 14 Each time point is as following: Daytime: 06:00~21:59 Nighttime: 22:00~05:59
Time frame: 14days
3 secondary outcomes
Cmax,ss of CKD-519
Time frame: 0(predose)~24 at day15
AUCτ,ss of CKD-519
Time frame: 0(predose)~24 at day15
Tmax,ss of CKD-519
Time frame: 0(predose)~24 at day15
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 23 Feb 2017.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 Soo Park, MD, PhD 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 200mg in people with Healthy Volunteers, 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 22 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 23 Feb 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. Some participants in this study may receive a placebo. 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?
Change in 24h average SBP and DBP from baseline to Day 14 Each time point is as following: Daytime: 06:00~21:59 Nighttime: 22:00~05:59 (time frame: 14days). 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 23 Feb 2017; AzTrials last refreshed its copy on 7 Nov 2026.