Cardiovascular DiseasesPhase 1NCT04906785
Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fed Conditions
A Phase 1 study testing CKD-385 and D744 in people with Cardiovascular Diseases, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fed Conditions Read more about this study
- Who is it for?
- Ages 19 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- CKD-385 and D744
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jun 2021to 6 Aug 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 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults age≥19 years and age<55 years at the time of screening
- Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg
- BMI = Weight(kg)/ Height(m)2
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
- Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/ bacterial, etc.) and vital signs, ECG etc. performed at screening
- Individuals who signed an informed consent form approved by the 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 product
- Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
- Individuals with the ability and willingness to participate the entire study period
Who cannot join
- Subject who has (or has histories of) clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological or allergic diseases(except for asymptomatic seasonal allergy at the time of administration) or evidence(except for simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
- Subject with a 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
- ALT or 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 of screening
- Subject who smokes more than one pack of cigarette a day within 6 months of screening
Show all 18Show fewer
- Subject who took other clinical trial drugs or bioequivalence test drugs within 3 months before the first administration of clinical trial drug
- Subject who conform to the specific items below
- systolic blood pressure less than 90 mmHg, greater than 140 mmHg or diastolic blood pressure less than 60 mmHg or greater than 90 mmHg in a sitting position
- Severe bradycardia (less than 50 beats/minute)
- Subject who has significant alcohol abuse or drug abuse within a year of screening
- Subject who took drugs which are known as disturbing drug metabolism within 30 days prior to the first administration of clinical trial drug.
- Subject who uses any of other drugs, including over-the-counter medications and prescription medications within 10 days prior to first administration of clinical trial drug.
- Subject who donated whole blood within 2 months prior to first administration of clinical trial drug or blood components within 1 month prior to first administration of clinical trial drug
- Subject who is hypersensitive to the components of a clinical trial drug or clinical trial drug itself.
- Subject had genetic dysfunctions like galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subject who is not able to consume high-fat meal provided during the clinical trial
- Subjects who were deemed inappropriate to participate in the study by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National University Hospital
Jeonju
Min-Gul Kim, Professor, +82632593480, mgkim@jbcp.kr
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 High-dose in Healthy Volunteers Under Fed Conditions
Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fed Conditions
Read the detailed description
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 high-dose in healthy volunteers under fed conditions
- Conditions
- Cardiovascular Diseases
- Being tested
- CKD-385, D744
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-385Drug
Test Drug
D744Drug
Reference Drug
| Study group | Role | What they receive |
|---|---|---|
| Sequence1 | Experimental | 1. Period 1: Reference drug(D744)
2. Period 2: Test drug(CKD-385) Receives: Drug: CKD-385; Drug: D744 |
| Sequence2 | Experimental | 1. Period 1: Test drug(CKD-385)
2. Period 2: Reference drug(D744) Receives: Drug: CKD-385; Drug: D744 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-385
Area under the concentration-time curve from time zero to time of CKD-385
Measured: Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Secondary outcomes (5)
AUCinf of CKD-385
Area under the concentration-time curve from zero up to infinity of CKD-385
Measured: Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Tmax of CKD-385
Time to maximum plasma concentration of CKD-385
Measured: Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
T1/2 of CKD-385
Terminal elimination half-life of CKD-385
Measured: Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
CL/F of CKD-385
Apparent clearance of CKD-385
Measured: Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Vd/F of CKD-385
Apparent Volume of Distribution of CKD-385
Measured: Pre-dose (0 hour), 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 posted28 May 2021
- Study start4 Jun 2021 (estimated)
- Primary completion30 Jul 2021 (estimated)
- Study completion6 Aug 2021 (estimated)
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
- 52 participants (estimated)
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
- NCT04906785
- Sponsor's protocol ID
- A88_11BE2110
- Status last verified
- May 2021
- First submitted
- 27 May 2021
- Last updated
- 28 May 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 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 High-dose in Healthy Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT04906785
- Acronym / sponsor ID
- A88_11BE2110
- Conditions
- Cardiovascular Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2021 (estimated)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 6 Aug 2021 (estimated)
- First posted
- 28 May 2021 (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.
Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fed Conditions
Detailed description
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 high-dose in healthy volunteers under fed conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence1 | Experimental | Drug: CKD-385, Drug: D7441. Period 1: Reference drug(D744) 2. Period 2: Test drug(CKD-385) |
| Sequence2 | Experimental | Drug: CKD-385, Drug: D7441. Period 1: Test drug(CKD-385) 2. Period 2: Reference drug(D744) |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adults age≥19 years and age<55 years at the time of screening
- Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
- Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/ bacterial, etc.) and vital signs, ECG etc. performed at screening
- Individuals who signed an informed consent form approved by the 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 product
Key exclusion criteria (18 listed)
- Subject who has (or has histories of) clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological or allergic diseases(except for asymptomatic seasonal allergy at the time of administration) or evidence(except for simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
- Subject with a 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
- ALT or 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 of 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 |
|---|---|---|
| CKD-385Test Drug | Drug | Sequence1, Sequence2 |
| D744Reference Drug | Drug | Sequence1, Sequence2 |
Primary outcome
AUCt of CKD-385
Time frame: Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Area under the concentration-time curve from time zero to time of CKD-385
5 secondary outcomes
AUCinf of CKD-385
Time frame: Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Tmax of CKD-385
Time frame: Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
T1/2 of CKD-385
Time frame: Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
CL/F of CKD-385
Time frame: Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Vd/F of CKD-385
Time frame: Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 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.
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 CKD-385 and D744 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 18 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: status not confirmed, as of the sponsor's last update on 28 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min-Gul Kim (+82632593480, mgkim@jbcp.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt of CKD-385 (time frame: Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours). 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 28 May 2021.