Hypertension and DyslipidemiaPhase 1NCT05552495
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-386 in Healthy Volunteers Under Fasting Conditions
A Phase 1 study testing CKD-386(4) F1, CKD-386(4) F2 and D013, D326, D337 in people with Hypertension and Dyslipidemia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-386 in healthy volunteers under fasting conditions. 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(4) F1, CKD-386(4) F2 and D013, D326, D337
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Sep 2022to 12 Dec 2022
- 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 adults volunteers aged ≥19 years
- Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) < 30 kg/m2 and total body weight ≥ 55 kg BMI = Weight(kg)/ Height(m)2
- Following vital signs results at screening
- Systolic blood pressure: 90 mmHg to 139 mmHg
- Diastolic blood pressure: 60 mmHg to 89 mmHg
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
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- Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, serology, urology etc.) and ECG etc. performed
- Individuals who agreed proper contraception during the study and did consent to not donation of sperm or eggs 14 days after the last dose of study drug
- Individuals who signed an informed consent form after being fully informed of the study prior to participation, including the objective and content
Who cannot join
- Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first administration of investigational drugs
- 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 (However, clinical investigational drugs) Participation is possible in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs)
- Individuals who donated whole blood within the 8 weeks, or blood components within 4 weeks or had a blood transfusion within 4 weeks prior to the first administration of investigational drugs
- Individuals who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery
- Individuals who meet the following condition with 1 month of the first administration of investigational drugs
- Alcohol: Man-21 glasses/week, Woman-14 glasses/week (1 glass = soju 50mL or liquor 30mL or beer 250mL)
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- 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
- Individuals who have genetic problems such as galactose intolerance, Lap lactase 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: A Phase I Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics of CKD-386 With Co-administration of D013, D326, and D337 in Healthy Adult Volunteers
This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-386 in healthy volunteers under fasting conditions.
Read the detailed description
To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 14 days Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
- Conditions
- Hypertension and Dyslipidemia
- Being tested
- CKD-386(4) F1, CKD-386(4) F2, D013, 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-386(4) F1Drug
Also called Test1
1 Tablet
CKD-386(4) F2Drug
Also called Test2
1 Tablet
D013, D326, D337Drug
Also called Reference
D013 1 Tablet, D326 1Tablet, D337 1 Tablet
| Study group | Role | What they receive |
|---|---|---|
| Reference-Test1-Test2 | Experimental | Not described Receives: Drug: CKD-386(4) F1; Drug: CKD-386(4) F2; Drug: D013, D326, D337 |
| Reference-Test2-Test1 | Experimental | Not described Receives: Drug: CKD-386(4) F1; Drug: CKD-386(4) F2; Drug: D013, D326, D337 |
| Test1-Reference-Test2 | Experimental | Not described Receives: Drug: CKD-386(4) F1; Drug: CKD-386(4) F2; Drug: D013, D326, D337 |
| Test1-Test2-Reference | Experimental | Not described Receives: Drug: CKD-386(4) F1; Drug: CKD-386(4) F2; Drug: D013, D326, D337 |
| Test2-Reference-Test1 | Experimental | Not described Receives: Drug: CKD-386(4) F1; Drug: CKD-386(4) F2; Drug: D013, D326, D337 |
| Test2-Test1-Reference | Experimental | Not described Receives: Drug: CKD-386(4) F1; Drug: CKD-386(4) F2; Drug: D013, D326, D337 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-386
Area under the CKD-386 concentration in blood-time curve from 0 to t
Measured: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours
Cmax of CKD-386
The maximum CKD-386 concentration in blood sampling time t
Measured: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 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 posted23 Sep 2022
- Study start23 Sep 2022
- Primary completion27 Nov 2022
- Study completion12 Dec 2022
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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaewoo Kim, M.D., Principal investigator, Gwanak-gu, Seoul, South Korea, 08779
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552495
- Sponsor's protocol ID
- A83_09BE2219P
- Status last verified
- Jan 2023
- First submitted
- 21 Sep 2022
- Last updated
- 12 Jan 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 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics of CKD-386 With Co-administration of D013, D326, and D337 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05552495
- Acronym / sponsor ID
- A83_09BE2219P
- Conditions
- Hypertension and Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 23 Sep 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.
This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-386 in healthy volunteers under fasting conditions.
Detailed description
To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 14 days Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Reference-Test1-Test2 | Experimental | Drug: CKD-386(4) F1, Drug: CKD-386(4) F2, Drug: D013, D326, D337 |
| Reference-Test2-Test1 | Experimental | Drug: CKD-386(4) F1, Drug: CKD-386(4) F2, Drug: D013, D326, D337 |
| Test1-Reference-Test2 | Experimental | Drug: CKD-386(4) F1, Drug: CKD-386(4) F2, Drug: D013, D326, D337 |
| Test1-Test2-Reference | Experimental | Drug: CKD-386(4) F1, Drug: CKD-386(4) F2, Drug: D013, D326, D337 |
| Test2-Reference-Test1 | Experimental | Drug: CKD-386(4) F1, Drug: CKD-386(4) F2, Drug: D013, D326, D337 |
| Test2-Test1-Reference | Experimental | Drug: CKD-386(4) F1, Drug: CKD-386(4) F2, Drug: D013, D326, D337 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy adults volunteers aged ≥19 years
- Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) < 30 kg/m2 and total body weight ≥ 55 kg BMI = Weight(kg)/ Height(m)2
- Following vital signs results at screening
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
- Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, serology, urology etc.) and ECG etc. performed
Key exclusion criteria (21 listed)
- Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first administration of investigational drugs
- 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 (However, clinical investigational drugs) Participation is possible in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs)
- Individuals who donated whole blood within the 8 weeks, or blood components within 4 weeks or had a blood transfusion within 4 weeks prior to the first administration of investigational drugs
- Individuals who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery
- Individuals who meet the following condition with 1 month of the first administration of investigational drugs
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-386(4) F1Also: Test11 Tablet | Drug | Reference-Test1-Test2, Reference-Test2-Test1, Test1-Reference-Test2, Test1-Test2-Reference, Test2-Reference-Test1, Test2-Test1-Reference |
| CKD-386(4) F2Also: Test21 Tablet | Drug | Reference-Test1-Test2, Reference-Test2-Test1, Test1-Reference-Test2, Test1-Test2-Reference, Test2-Reference-Test1, Test2-Test1-Reference |
| D013, D326, D337Also: ReferenceD013 1 Tablet, D326 1Tablet, D337 1 Tablet | Drug | Reference-Test1-Test2, Reference-Test2-Test1, Test1-Reference-Test2, Test1-Test2-Reference, Test2-Reference-Test1, Test2-Test1-Reference |
Primary outcome
AUCt of CKD-386
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours
Area under the CKD-386 concentration in blood-time curve from 0 to t
Cmax of CKD-386
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours
The maximum CKD-386 concentration in blood sampling time t
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 12 Jan 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.
Jaewoo Kim, M.D. principal investigator
Gwanak-gu, Seoul, South Korea, 08779
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(4) F1, CKD-386(4) F2 and D013, 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 21 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 12 Jan 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?
AUCt of CKD-386 (time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 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 12 Jan 2023.