Type II Diabetes MellitusPhase 1CKD-379NCT06652971
A Clinical Trial to Evaluate the Food Effect of CKD-379
A Phase 1 study testing CKD-379 in people with Type II Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A clinical trial to evaluate the food effect of CKD-379 Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- CKD-379
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Nov 2024to 17 Dec 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult aged 19 or older and 55 or younger at screening
- Body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0kg/m2 and Body weight ≥ 50kg
- Those with systolic blood pressure ≤ 150 mmHg and ≥ 90 mmHg, diastolic blood pressure ≤ 100 mmHg and ≥ 50 mmHg
- A person who has no clinically significant congenital or chronic diseases and has no pathological symptoms or findings as a result of medical examination
- A person determined to be suitable for testing as a result of diagnostic tests and electrocardiogram (ECG) established and performed according to the characteristics of the drug during screening
- From the date of first administration of the clinical trial drug to the date 7 days after the last administration, either you or your spouse agrees to exclude the possibility of pregnancy using medically appropriate contraception* and to not provide sperm or eggs
- After hearing and fully understanding the full explanation for this clinical trial, the person who voluntarily decides to participate and agrees to comply with the precautions
Who cannot join
- A person who has taken a drug metabolase-inducing and inhibiting drug, such as barbitals, within 30 days before the start of the test (the first day of administration), or who has taken a drug that may interfere with the main test within 10 days before the start of the test (the first day of administration)
- Anyone who has consumed excessive smoking or caffeine or alcohol within one month prior to the first administration of the clinical trial drug (caffeine: > 5 cups/day, alcohol: male: > 21 cups/week, female: > 14 cups/week, tobacco: > 20 cigarettes/day), or who cannot stop smoking, caffeine and alcohol consumption during each hospitalization period
- Where the tester determines that the drug may affect the test or the safety of the subject, if the drug is administered within 14 days before the first administration of the clinical trial drug or the general drug including health food and vitamin preparations within 7 days
- A person who has participated in clinical trials (including biological equivalence tests) and administered experimental drugs within 6 months before the start of the trial (the first dosing date)
- A person who has donated whole blood within 8 weeks before the start of the test (the first medication date) or donated ingredients within 2 weeks or received a blood transfusion within 4 weeks
- A person who has a history of gastrointestinal diseases (Cron's disease, ulcerative colitis, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of drugs
Show all 19Show fewer
- A person who has a clinically significant disease or mental illness corresponding to the biliary tract, kidney, nervous system, immune system, respiratory system, urinary system, digestive system, endocrine system, blood and tumor, cardiovascular system, musculoskeletal system, or has the following manifestations or past history
- Patients with type 1 diabetes, acute or chronic metabolic acidosis, and those with a history of ketoacidosis (including diabetic ketoacidosis), diabetic comas and total marriages, lactic acidosis, etc
- Patients with severe heart failure or a history of heart failure (New York Heart Association (NYHA) classification 1,2,3,4 heart conditions)
- liver dysfunction
- Patients with moderate to severe renal impairment (eGFR <60 mL/min/1.73 m2)
- Patients undergoing tests for intravenous administration of radioiodine contrast agents
- Before and after 48 hours of surgery, patients with dehydration, severe infection or severe traumatic systemic disorder, acute myocardial infarction, sepsis
- patients with malnutrition, starvation, weakness, pituitary dysfunction or adrenal insufficiency
- As a result of performing a diagnostic test at the time of screening, a person who shows the following figures: AST or ALT or total bilirubin more than twice the upper limit of normal range
- A person who has a history of clinically significant hypersensitivity reactions to other drugs or additives, including clinical trial drug
- A person who has a history of drug abuse within one year of screening
- In the case of women who are pregnant women and pregnant women who are pregnant or pregnant
- A person who determines that the investigator is not suitable for participating in the clinical trial due to other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dose, Cross-over Phase 1 Study to Evaluate the Effect of Food on Pharmacokinetic Characteristics and Safety of CKD-379 in Healthy Adult Volunteers
A clinical trial to evaluate the food effect of CKD-379
Read the detailed description
A randomized, open-label, single-dose, cross-over phase 1 study to evaluate the effect of food on pharmacokinetic characteristics and safety of CKD-379 in healthy adult volunteers
- Conditions
- Type II Diabetes Mellitus
- Being tested
- CKD-379
- 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-379Drug
QD, PO
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1: A single oral dose of 1 tablet under fasting condition Period 2: A single oral dose of 1 tablet under fed condition Receives: Drug: CKD-379 |
| Sequence 2 | Experimental | Period 1: A single oral dose of 1 tablet under fed condition Period 2: A single oral dose of 1 tablet under fasting condition Receives: Drug: CKD-379 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-379
Area under the concentration-time curve time zero to time
Measured: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours]
Cmax of CKD-379
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, 5, 6, 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 posted22 Oct 2024
- Study start5 Nov 2024
- Primary completion4 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652971
- Sponsor's protocol ID
- A125_06FDI2411
- Acronym
- CKD-379
- Status last verified
- Dec 2024
- First submitted
- 21 Oct 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Cross-over Phase 1 Study to Evaluate the Effect of Food on Pharmacokinetic Characteristics and Safety of CKD-379 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06652971
- Acronym / sponsor ID
- CKD-379 / A125_06FDI2411
- Conditions
- Type II Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 22 Oct 2024 (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 food effect of CKD-379
Detailed description
A randomized, open-label, single-dose, cross-over phase 1 study to evaluate the effect of food on pharmacokinetic characteristics and safety of CKD-379 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-379Period 1: A single oral dose of 1 tablet under fasting condition Period 2: A single oral dose of 1 tablet under fed condition |
| Sequence 2 | Experimental | Drug: CKD-379Period 1: A single oral dose of 1 tablet under fed condition Period 2: A single oral dose of 1 tablet under fasting condition |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult aged 19 or older and 55 or younger at screening
- Body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0kg/m2 and Body weight ≥ 50kg
- Those with systolic blood pressure ≤ 150 mmHg and ≥ 90 mmHg, diastolic blood pressure ≤ 100 mmHg and ≥ 50 mmHg
- A person who has no clinically significant congenital or chronic diseases and has no pathological symptoms or findings as a result of medical examination
- A person determined to be suitable for testing as a result of diagnostic tests and electrocardiogram (ECG) established and performed according to the characteristics of the drug during screening
Key exclusion criteria (19 listed)
- A person who has taken a drug metabolase-inducing and inhibiting drug, such as barbitals, within 30 days before the start of the test (the first day of administration), or who has taken a drug that may interfere with the main test within 10 days before the start of the test (the first day of administration)
- Anyone who has consumed excessive smoking or caffeine or alcohol within one month prior to the first administration of the clinical trial drug (caffeine: > 5 cups/day, alcohol: male: > 21 cups/week, female: > 14 cups/week, tobacco: > 20 cigarettes/day), or who cannot stop smoking, caffeine and alcohol consumption during each hospitalization period
- Where the tester determines that the drug may affect the test or the safety of the subject, if the drug is administered within 14 days before the first administration of the clinical trial drug or the general drug including health food and vitamin preparations within 7 days
- A person who has participated in clinical trials (including biological equivalence tests) and administered experimental drugs within 6 months before the start of the trial (the first dosing date)
- A person who has donated whole blood within 8 weeks before the start of the test (the first medication date) or donated ingredients within 2 weeks or received a blood transfusion within 4 weeks
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-379QD, PO | Drug | Sequence 1, Sequence 2 |
Primary outcome
AUCt of CKD-379
Time frame: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours]
Area under the concentration-time curve time zero to time
Cmax of CKD-379
Time frame: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours
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 30 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-379 in people with Type II Diabetes Mellitus, 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 19 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 30 Dec 2024. 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-379 (time frame: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 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 30 Dec 2024.