Type 2 DiabetesPhase 1NCT05113693
Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393
A Phase 1 study testing CKD-393 and CKD-501, D759, H053 in people with Type 2 Diabetes, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Objective Evaluation of the pharmacokinetic properties and safety of CKD-393 0.25/50/750 mg oral administration in healthy adults under fed condition. Read more about this study
- Who is it for?
- Ages 19 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CKD-393 and CKD-501, D759, H053
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Nov 2021to 10 Dec 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 adult volunteers aged 19 ≤ ~ < 55-year-old.
- Weight ≥55kg (man) or 45kg (woman), with calculated body mass index (BMI) of 17.5 ≤ ~ < 30.5 kg/m2.
- Those who have no congenital diseases or chronic diseases within 3 years 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.
- Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
- Those who agree to contraception until the 1 month after last administration of clinical trial drugs.
- Those who have the ability and willingness to participate during the entire clinical trail.
Who cannot join
- Those who have clinically significant disease or medical history of heart failure, Hepatopathy, Type 1 Diabetes, Diabetic ketoacidosis, Edema, Renal dysfunction, galactose intolerance, glucose-galactose malabsorption. And Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) during clinical trial.
- Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of investigational drug.
- Those who have the test results written below
- AST, ALT > 2 times higher than upper normal level
- Those who exceeding an alcohol consumption criteria(210g/week) within 6 months before the first administration of investigational drug.
- Beer 1 glass(250ml, Alcohol contents 5%) = 10g
Show all 22Show fewer
- Soju 1 glass(50ml, Alcohol contents 20%) = 8g
- Wine 1 glass(125ml, Alcohol contents 12%) = 12g
- Those who exceeding smoking criteria(20 cigarettes/day) within 6 months before the first administration of investigational drug.
- Those who received investigational durg by participating in other clinical trial within 6 months before the first administration of investigational drug.
- Those who have vital sign written below
- systolic blood pressure ≥140 mmHg or < 90 mmHg
- diastolic blood pressure ≥ 90 mmHg or < 60 mmHg
- Those who have a drug or alcohol abuse history within 1 year before the first administration of investigational drug.
- Those who take barbiturate and related (causing induction or inhibition. of metabolism) drug within 30 days before the first administration of investigational drug.
- Those who received Ethical-the-counter (ETC) drugs or Over-the-counter (OTC) drugs within 10 days before the first administration of investigational drug.
- Those who donated whole blood within 2 months or apheresis within 1 month before the first administration of investigational drug.
- Those who severe acute/chronic medical or mental condition which can increase the safety risk by administration of investigational drug.
- Those who have history of hypersensitivity to active pharmaceutical ingredient or additives.
- Those who are pregnant or breastfeeding.
- Those who can't ingest a high fat diet.
- Those who are deemed inappropriate to participate in clinical trial by investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393 in Healthy Volunteers Under Fed Conditions
Objective
- Evaluation of the pharmacokinetic properties and safety of CKD-393 0.25/50/750 mg oral administration in healthy adults under fed condition.
- Conditions
- Type 2 Diabetes
- Being tested
- CKD-393, CKD-501, D759, H053
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-393Drug
QD, PO
CKD-501, D759, H053Drug
QD, PO
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Period 1 - A single dose of 4 tablets(CKD-501 1T, D759 1T, H053 2T) under fed condition.
Period 2 - A single dose of 2 tablets(CKD-393 2T) under fed condition. Receives: Drug: CKD-393; Drug: CKD-501, D759, H053 |
| 2 | Experimental | Period 1 - A single dose of 2 tablets(CKD-393 2T) under fed condition.
Period 2 - A single dose of 4 tablets(CKD-501 1T, D759 1T, H053 2T) under fed condition. Receives: Drug: CKD-393; Drug: CKD-501, D759, H053 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-501, D759, H053
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, 2.5, 3, 4, 6, 8, 12, 24, 48 hour
Cmax of CKD-501, D759, H053
Cmax: Maximum plasma concentration of the drug
Measured: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start25 Nov 2021
- Primary completion6 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Gul Kim, M.D, Ph.D., Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113693
- Sponsor's protocol ID
- A98_05BE2118
- Status last verified
- Jun 2023
- First submitted
- 28 Oct 2021
- Last updated
- 9 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. 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-393 in Healthy Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT05113693
- Acronym / sponsor ID
- A98_05BE2118
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 9 Nov 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.
Objective
- Evaluation of the pharmacokinetic properties and safety of CKD-393 0.25/50/750 mg oral administration in healthy adults under fed condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CKD-393, Drug: CKD-501, D759, H053Period 1 - A single dose of 4 tablets(CKD-501 1T, D759 1T, H053 2T) under fed condition. Period 2 - A single dose of 2 tablets(CKD-393 2T) under fed condition. |
| 2 | Experimental | Drug: CKD-393, Drug: CKD-501, D759, H053Period 1 - A single dose of 2 tablets(CKD-393 2T) under fed condition. Period 2 - A single dose of 4 tablets(CKD-501 1T, D759 1T, H053 2T) under fed condition. |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult volunteers aged 19 ≤ ~ < 55-year-old.
- Weight ≥55kg (man) or 45kg (woman), with calculated body mass index (BMI) of 17.5 ≤ ~ < 30.5 kg/m2.
- Those who have no congenital diseases or chronic diseases within 3 years 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.
- Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
Key exclusion criteria (22 listed)
- Those who have clinically significant disease or medical history of heart failure, Hepatopathy, Type 1 Diabetes, Diabetic ketoacidosis, Edema, Renal dysfunction, galactose intolerance, glucose-galactose malabsorption. And Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) during clinical trial.
- Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of investigational drug.
- Those who have the test results written below
- Those who exceeding an alcohol consumption criteria(210g/week) within 6 months before the first administration of investigational drug.
- Those who exceeding smoking criteria(20 cigarettes/day) within 6 months before the first administration of investigational drug.
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-393QD, PO | Drug | 1, 2 |
| CKD-501, D759, H053QD, PO | Drug | 1, 2 |
Primary outcome
AUCt of CKD-501, D759, H053
Time frame: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hour
AUCt: Area under the concentration-time curve from time zero to time
Cmax of CKD-501, D759, H053
Time frame: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hour
Cmax: Maximum plasma concentration of the drug
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 9 Jun 2023.
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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, M.D, Ph.D. 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-393 and CKD-501, D759, H053 in people with Type 2 Diabetes, 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 7 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 9 Jun 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-501, D759, H053 (time frame: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hour). 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 9 Jun 2023.