Type 2 Diabetes Mellitus (T2DM)Phase 1CKD-383 FDI P1NCT06695572
Clinical Study to Evaluate the Food Effect of CKD-383 0.5/10/1000mg in Healthy Volunteers
A Phase 1 study testing CKD-383 in people with Type 2 Diabetes Mellitus (T2DM), 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 food effect of CKD-383 in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- CKD-383
- 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
- 6 Nov 2024to 13 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 adults volunteers between the ages of 19 years to 55 years.
- Individuals who had 18.0 kg/m2 ≤ Body Mass Index(BMI) < 30.0 kg/m2 and total body weight ≥ 50 kg (woman total body weight ≥ 45 kg) BMI = Weight(kg)/ Height(m)2
- Following vital signs results at screening
- Systolic blood pressure: 90 mmHg to 150 mmHg
- Diastolic blood pressure: 50 mmHg to 100 mmHg
- Individuals who is determined by investigators to be suitable as a test subject as a result of the examination conducted at the time of screening
- Individuals who agreed proper contraception during the study and did consent to not donation of sperm 7 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
- Clinically significant biliary tract (such as hepatic dysfunction, liver failure, etc.), kidney (stage 3b), and severe renal impairment (eGFR <60 mL/min/1.73 m2), nervous system, immune system, respiratory system (such as pulmonary infarction, severe pulmonary dysfunction and other hypoxemia prone conditions, respiratory failure, etc.), urinary system, digestive system (such as diarrhea and vomiting), endocrine system, blood and tumor, cardiovascular system (acute myocardial infarction, shock, acute and unstable heart failure, decompensated heart failure, severe heart failure, or those with a history of heart failure (such as New York Heart Association(NYHA) Classification 3 and 4 heart failure)
- Acute or chronic metabolic acid patients with type 1 diabetes, lactic acidosis, diabetic ketoacidosis with or without a coma, and diabetic ketoacidosis patients
- Patients with diabetic comas and ex-marriage
- Individuals who have an acute condition that can change his or her renal function, such as dehydration, before and after surgery, severe infection, severe traumatic systemic disorder, cardiovascular collapse (shock), sepsis, etc
- Patients undergoing intravenous examination of radiodine contrast agents (e.g., intravenous urinary tract, intravenous cholangiography, angiography, computed tomography with contrast agents, etc.)
- Patients with malnutrition, starvation, weakness, pituitary dysfunction or adrenal insufficiency
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- Individuals who have 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
- Individuals who have a history of clinically significant hypersensitivity reactions to the main components and components of clinical trial drugs and other drugs (viguanide drugs, thiazolidinedione drugs, etc.)
- Individuals who have a history of drug abuse within one year of screening or who has tested positive for a urine drug test
- Pregnant women, women who may be pregnant, nursing women
- Those who consumed excessive smoking or caffeine or alcohol within one month prior to the first administration of clinical trial drugs (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
- If the investigators determines that the drug may affect the clinical trial or the safety of the subject by administering prescription drugs or herbal medicines within 14 days prior to the first administration of investigational product or general medicines including health foods and vitamin preparations within 7 days
- Individuals who have taken a drug metabolase-inducing and inhibiting drug, such as barbitals, within 30 days prior to the first administration of investigational product
- Individuals who had been administered investigational product from other clinical study(include bioequivalence study) within the 6 months prior to the first administration of investigational drugs
- Individuals who donated whole blood within the 8 weeks, or blood components within 2 weeks or had a blood transfusion within 30 days prior to the first administration of investigational drugs
- Those who are deemed insufficient to participate in this clinical study by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Single Dose, Crossover, Phase I Study to Evaluate the Effects of Food on Pharmacokinetics and the Safety of CKD-383 in Healthy Adult Volunteers
This study is a randomized, open-label, single dose, crossover study to evaluate the food effect of CKD-383 in healthy volunteers
Read the detailed description
To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is 7 days
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- CKD-383
- 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-383Drug
QD, PO
| Study group | Role | What they receive |
|---|---|---|
| Fast-Fed | 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-383 |
| Fed-Fast | 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-383 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-383
Area under the CKD-383 concentration in blood-time curve from 0 to t
Measured: 0, 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-383
The maximum CKD-383 concentration in blood sampling time t
Measured: 0, 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 posted19 Nov 2024
- Study start6 Nov 2024
- Primary completion7 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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)
- Collaborators
- Bumin Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695572
- Sponsor's protocol ID
- A101_07FDI2413
- Acronym
- CKD-383 FDI P1
- Status last verified
- May 2025
- First submitted
- 17 Nov 2024
- Last updated
- 21 May 2025
- 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single Dose, Crossover, Phase I Study to Evaluate the Effects of Food on Pharmacokinetics and the Safety of CKD-383 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06695572
- Acronym / sponsor ID
- CKD-383 FDI P1 / A101_07FDI2413
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Bumin Hospital
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 7 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 19 Nov 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.
This study is a randomized, open-label, single dose, crossover study to evaluate the food effect of CKD-383 in healthy volunteers
Detailed description
To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is 7 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast-Fed | Experimental | Drug: CKD-383Period 1: A single oral dose of 1 tablet under fasting condition, Period 2: A single oral dose of 1 tablet under fed condition |
| Fed-Fast | Experimental | Drug: CKD-383Period 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 (8 listed)
- Healthy adults volunteers between the ages of 19 years to 55 years.
- Individuals who had 18.0 kg/m2 ≤ Body Mass Index(BMI) < 30.0 kg/m2 and total body weight ≥ 50 kg (woman total body weight ≥ 45 kg) BMI = Weight(kg)/ Height(m)2
- Following vital signs results at screening
- Individuals who is determined by investigators to be suitable as a test subject as a result of the examination conducted at the time of screening
- Individuals who agreed proper contraception during the study and did consent to not donation of sperm 7 days after the last dose of study drug
Key exclusion criteria (16 listed)
- Clinically significant biliary tract (such as hepatic dysfunction, liver failure, etc.), kidney (stage 3b), and severe renal impairment (eGFR <60 mL/min/1.73 m2), nervous system, immune system, respiratory system (such as pulmonary infarction, severe pulmonary dysfunction and other hypoxemia prone conditions, respiratory failure, etc.), urinary system, digestive system (such as diarrhea and vomiting), endocrine system, blood and tumor, cardiovascular system (acute myocardial infarction, shock, acute and unstable heart failure, decompensated heart failure, severe heart failure, or those with a history of heart failure (such as New York Heart Association(NYHA) Classification 3 and 4 heart failure)
- Acute or chronic metabolic acid patients with type 1 diabetes, lactic acidosis, diabetic ketoacidosis with or without a coma, and diabetic ketoacidosis patients
- Patients with diabetic comas and ex-marriage
- Individuals who have an acute condition that can change his or her renal function, such as dehydration, before and after surgery, severe infection, severe traumatic systemic disorder, cardiovascular collapse (shock), sepsis, etc
- Patients undergoing intravenous examination of radiodine contrast agents (e.g., intravenous urinary tract, intravenous cholangiography, angiography, computed tomography with contrast agents, etc.)
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-383QD, PO | Drug | Fast-Fed, Fed-Fast |
Primary outcome
AUCt of CKD-383
Time frame: 0, 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 CKD-383 concentration in blood-time curve from 0 to t
Cmax of CKD-383
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours
The maximum CKD-383 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 21 May 2025.
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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-383 in people with Type 2 Diabetes Mellitus (T2DM), 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 16 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 21 May 2025. 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-383 (time frame: 0, 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 21 May 2025.