Hypertension and DyslipidemiaPhase 1NCT04673864
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386
A Phase 1 study testing CKD-386 and D012, D326, D337 in people with Hypertension and Dyslipidemia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-386 Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension and Dyslipidemia
- What is being tested?
- CKD-386 and D012, D326, D337
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2021to 30 Mar 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 ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
- Those who meet the blood pressure criteria during screening tests:
- Systolic Blood Pressure: 90 to 139 mmHg
- Diastolic Blood Pressure: 60 to 89 mmHg
- Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
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- Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
- Those who agree to contraception during the participation of clinical trial.
- Individuals 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 received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
- Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
- Those who donated whole blood or apheresis within 2 months or 1 month respectfully, or received blood transfusion within a month.
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
- Those who exceed an alcohol and cigarette consumption than below criteria
- Alcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass:
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- Soju 50mL, Wine 30mL, or beer 250mL)
- Smoking: 20 cigarettes/day
- Patients with the following diseases
- Patients with hypersensitivity to the main constituents or components of the investigational drug
- Severe hepatic impairment, biliary atresia or cholestasis
- Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists
- Diabetes mellitus
- Patients with moderate to severe renal impairment [glomerular filtration rate (eGFR) <60 mL / min / 1.73m^2]
- Renal vascular hypertension patients
- Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit
- Patients with myopathy or have a history of family or genetic history of myopathy
- Hypothyroidism
- If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs
- Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
- Those who are deemed insufficient to participate in this clinical study by investigators.
- Woman who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Single Dose, 2-sequence, 4-period, Cross-over Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-386 With Co-administration of D012, D326, and D337 in Healthy Adult Volunteers
A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-386
Read the detailed description
An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-386 with co-administration of D012, D326, and D337 in healthy adult volunteers
- Conditions
- Hypertension and Dyslipidemia
- Being tested
- CKD-386, D012, D326, D337
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-386Drug
QD, PO
D012, D326, D337Drug
QD, PO
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1: D012, D326, D337- A single oral dose of 3 tablets under fasting condition
Period 2: CKD-386- A single oral dose of 1 tablet under fasting condition
Period 3: D012, D326, D337- A single oral dose of 3 tablets under fasting condition
Period 4: CKD-386- A single oral dose of 1 tablet under fasting condition Receives: Drug: CKD-386; Drug: D012, D326, D337 |
| Sequence 2 | Experimental | Period 1: CKD-386- A single oral dose of 1 tablet under fasting condition
Period 2: D012, D326, D337- A single oral dose of 3 tablets under fasting condition
Period 3: CKD-386- A single oral dose of 1 tablet under fasting condition
Period 4: D012, D326, D337- A single oral dose of 3 tablets under fasting condition Receives: Drug: CKD-386; Drug: D012, D326, D337 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-386
AUCt: Area under the concentration-time curve from time zero to time
Measured: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Cmax of CKD-386
Maximum plasma concentration of the drug
Measured: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Secondary outcomes (4)
AUCinf of CKD-386
AUCinf: Area under the concentration-time curve from zero up to ∞
Measured: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Tmax of CKD-386
Tmax: Time to maximum plasma concentration
Measured: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
AUCt/AUCinf of CKD-386
AUCt/AUCinf
Measured: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
T1/2 of CKD-386
T1/2: Terminal elimination half-life
Measured: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start17 Jan 2021
- Primary completion4 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension and 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noh Yook-Hwan, M.D., PhD., Principal investigator, H Plus Yangji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673864
- Sponsor's protocol ID
- A83_06BE1919
- Status last verified
- Jul 2021
- First submitted
- 13 Dec 2020
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- 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 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single Dose, 2-sequence, 4-period, Cross-over Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-386 With Co-administration of D012, D326, and D337 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04673864
- Acronym / sponsor ID
- A83_06BE1919
- Conditions
- Hypertension and Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2021 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 17 Dec 2020 (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 Tolerability of CKD-386
Detailed description
An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-386 with co-administration of D012, D326, 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: CKD-386, Drug: D012, D326, D337Period 1: D012, D326, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-386- A single oral dose of 1 tablet under fasting condition Period 3: D012, D326, D337- A single oral dose of 3 tablets under fasting condition Period 4: CKD-386- A single oral dose of 1 tablet under fasting condition |
| Sequence 2 | Experimental | Drug: CKD-386, Drug: D012, D326, D337Period 1: CKD-386- A single oral dose of 1 tablet under fasting condition Period 2: D012, D326, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-386- A single oral dose of 1 tablet under fasting condition Period 4: D012, D326, D337- A single oral dose of 3 tablets under fasting condition |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy adult volunteers aged ≥ 19 years
- Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
- Those who meet the blood pressure criteria during screening tests:
- 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 chemistry, serology, urology) and 12-lead ECG results at screening.
Key exclusion criteria (22 listed)
- Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
- Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
- Those who donated whole blood or apheresis within 2 months or 1 month respectfully, or received blood transfusion within a month.
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
- Those who exceed an alcohol and cigarette consumption than below criteria
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-386QD, PO | Drug | Sequence 1, Sequence 2 |
| D012, D326, D337QD, PO | Drug | Sequence 1, Sequence 2 |
Primary outcome
AUCt of CKD-386
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
AUCt: Area under the concentration-time curve from time zero to time
Cmax of CKD-386
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Maximum plasma concentration of the drug
4 secondary outcomes
AUCinf of CKD-386
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Tmax of CKD-386
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
AUCt/AUCinf of CKD-386
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
T1/2 of CKD-386
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
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 7 Jul 2021.
- 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.
Noh Yook-Hwan, M.D., PhD. principal investigator
H Plus Yangji 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-386 and D012, D326, D337 in people with Hypertension and 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 9 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 7 Jul 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?
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?
AUCt of CKD-386 (time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours). 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 7 Jul 2021.