Cardiovascular DiseasesPhase 1NCT04083846
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
A Phase 1 study testing Reference drug, Test drug 1 and Test drug 2 in people with Cardiovascular Diseases, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is a randomized, open-label, fed, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Reference drug, Test drug 1 and Test drug 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Sep 2019to 25 Oct 2019
- 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 aged over 19 at the time of screening
- Subject who had 17.5kg/m² ≤ Body Mass Index (BMI) < 30.5kg/m² and a total body weight ≥ 55 kg
- # BMI=Weight(kg) / Height(m)²
- Subject without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
- Subject who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG etc.)
- Subject who signed an informed consent form approved by the Institutional Review Board(IRB) of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational drug
- Subject who must consent to the use of reliable contraception and not to donate sperm, from the 1st administration of the investigational product until 1 month after the last administration of investigational product
- Subject with the ability and willingness to participate during the study period
Who cannot join
- Subject who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases
- Subject with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug
- Subject who shows the following values as a result of laboratory tests
- Alanine Transaminase(ALT) or Aspartate Transaminase(AST) > 2 times upper limit of normal range
- Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months prior to screening
- Subject who smokes more than 20 cigarettes a day within 6 months prior to screening
Show all 17Show fewer
- Subject who took other clinical trial drugs or bioequivalence test drugs within 6 months before the first administration of clinical trial drug
- Subject who conform to the specific items below
- systolic blood pressure less than 90 mmHg, not less than 140 mmHg or diastolic blood pressure less than 60 mmHg or not less than 90 mmHg in a sitting position
- Severe bradycardia (less than 50 beats/minute)
- Subject who has a medical history of significant alcohol abuse or drug abuse within one year prior to screening
- Subject who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first administration of investigational product(s).
- Subject who uses any of other drugs, including over-the-counter medications and prescription medications within 10 days prior to first administration of investigational product(s).
- Subject who donated whole blood within 2 months, or blood components within 1 month prior to first administration of investigational product(s).
- Subject who has hypersensitivity to investigational product(s) or investigational product(s) ingredient.
- Subject is unable to consume a high-fat meal provided during the study.
- Subject who were deemed to be inappropriate to participate in the study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fed Conditions
This study is a randomized, open-label, fed, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions.
Read the detailed description
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: D744, Test drug 1: CKD-385 64 mg formulation I, Test drug 2: CKD-385 64 mg formulation II. Pharmacokinetic blood samples are collected up to 48 hrs. The pharmacokinetic characteristics and safety are assessed.
- Conditions
- Cardiovascular Diseases
- Being tested
- Reference drug, Test drug 1, Test drug 2
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference drugDrug
Also called D744
D744 Cap. 1 Cap., single oral administration under fed condition
Test drug 1Drug
Also called CKD-385 64 mg formulation I
CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fed condition
Test drug 2Drug
Also called CKD-385 64 mg formulation II
CKD-385 64 mg formulation II Tab. 1 Tab., single oral administration under fed condition
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 1. Period 1: Reference drug
2. Period 2: Test drug 1
3. Period 3: Test drug 2 Receives: Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2 |
| Group 2 | Experimental | 1. Period 1: Test drug 2
2. Period 2: Reference drug
3. Period 3: Test drug 1 Receives: Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2 |
| Group 3 | Experimental | 1. Period 1: Test drug 1
2. Period 2: Test drug 2
3. Period 3: Reference drug Receives: Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2 |
| Group 4 | Experimental | 1. Period 1: Test drug 2
2. Period 2: Test drug 1
3. Period 3: Reference drug Receives: Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2 |
| Group 5 | Experimental | 1. Period 1: Test drug 1
2. Period 2: Reference drug
3. Period 3: Test drug 2 Receives: Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2 |
| Group 6 | Experimental | 1. Period 1: Reference drug
2. Period 2: Test drug 2
3. Period 3: Test drug 1 Receives: Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve last(AUCt)
Area under the plasma concentration time curve of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744, from time zero up to the last measurable concentration.
Measured: Pre-dose (0 hour), post-dose 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Cmax
The maximum concentration observed of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744 over blood sampling time.
Measured: Pre-dose (0 hour), post-dose 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start6 Sep 2019
- Primary completion21 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-gul Kim, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083846
- Sponsor's protocol ID
- A88_04BE1911P
- Status last verified
- Feb 2020
- First submitted
- 8 Sep 2019
- Last updated
- 5 Feb 2020
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT04083846
- Acronym / sponsor ID
- A88_04BE1911P
- Conditions
- Cardiovascular Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 10 Sep 2019 (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, fed, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions.
Detailed description
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: D744, Test drug 1: CKD-385 64 mg formulation I, Test drug 2: CKD-385 64 mg formulation II. Pharmacokinetic blood samples are collected up to 48 hrs. 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 |
|---|---|---|
| Group 1 | Experimental | Drug: Reference drug, Drug: Test drug 1, Drug: Test drug 21. Period 1: Reference drug 2. Period 2: Test drug 1 3. Period 3: Test drug 2 |
| Group 2 | Experimental | Drug: Reference drug, Drug: Test drug 1, Drug: Test drug 21. Period 1: Test drug 2 2. Period 2: Reference drug 3. Period 3: Test drug 1 |
| Group 3 | Experimental | Drug: Reference drug, Drug: Test drug 1, Drug: Test drug 21. Period 1: Test drug 1 2. Period 2: Test drug 2 3. Period 3: Reference drug |
| Group 4 | Experimental | Drug: Reference drug, Drug: Test drug 1, Drug: Test drug 21. Period 1: Test drug 2 2. Period 2: Test drug 1 3. Period 3: Reference drug |
| Group 5 | Experimental | Drug: Reference drug, Drug: Test drug 1, Drug: Test drug 21. Period 1: Test drug 1 2. Period 2: Reference drug 3. Period 3: Test drug 2 |
| Group 6 | Experimental | Drug: Reference drug, Drug: Test drug 1, Drug: Test drug 21. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy adult aged over 19 at the time of screening
- Subject who had 17.5kg/m² ≤ Body Mass Index (BMI) < 30.5kg/m² and a total body weight ≥ 55 kg
- # BMI=Weight(kg) / Height(m)²
- Subject without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
- Subject who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG etc.)
Key exclusion criteria (17 listed)
- Subject who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases
- Subject with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug
- Subject who shows the following values as a result of laboratory tests
- Alanine Transaminase(ALT) or Aspartate Transaminase(AST) > 2 times upper limit of normal range
- Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months prior to screening
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 |
|---|---|---|
| Reference drugAlso: D744D744 Cap. 1 Cap., single oral administration under fed condition | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Test drug 1Also: CKD-385 64 mg formulation ICKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fed condition | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Test drug 2Also: CKD-385 64 mg formulation IICKD-385 64 mg formulation II Tab. 1 Tab., single oral administration under fed condition | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Area Under Curve last(AUCt)
Time frame: Pre-dose (0 hour), post-dose 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Area under the plasma concentration time curve of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744, from time zero up to the last measurable concentration.
Cmax
Time frame: Pre-dose (0 hour), post-dose 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
The maximum concentration observed of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744 over blood sampling time.
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 5 Feb 2020.
- 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.
Min-gul Kim principal investigator
Chonbuk National University 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 Reference drug, Test drug 1 and Test drug 2 in people with Cardiovascular Diseases, 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 17 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 5 Feb 2020. 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?
Area Under Curve last(AUCt) (time frame: Pre-dose (0 hour), post-dose 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 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 5 Feb 2020.