Type II Diabetes MellitusPhase 1NCT06386328
A Clinical Trial to Evaluate the Food Effect of CKD-378
A Phase 1 study testing CKD-378, QD, PO 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-378 Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- CKD-378, QD, PO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 May 2024to 13 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult aged ≥ 19 at screening
- Body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0kg/m2 and Body weight ≥ 50kg
- Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination
- A person who is deemed suitable as a subject as a result of screening such as clinical laboratory examination (hematology, blood chemistry, serological tests, urinalysis, etc.), electrocardiogram examination, etc.
- A person who has received a sufficient explanation of the purpose and contents of the clinical trial and has agreed in writing voluntarily to participate in the clinical trial
- A person who has agreed to use appropriate contraception and not donate sperm or eggs until 1 week after the first administration of the drug and the last administration of the drug
Who cannot join
- Those who have taken a drug known to significantly induce or inhibit drug metabolizing enzymes within 30 days before the first administration of investigational product, or who have taken drug that may interfere with this investigational product within 10 days
- Those with a history of regular alcohol intake before the first administration of investigational product
- More than 21 drinks/week for men
- More than 14 drinks/week for women
- Those who have taken other investigational product within 6 months before the first administration of the investigational product
- Those who have donated whole blood within 8 weeks or donated component blood within 2 weeks or received blood transfusion within 4 weeks before the first administration of the investigational product
Show all 22Show fewer
- Those with a history of gastrointestinal diseases or surgery (except simple appendicectomy, hernia surgery) that may affect drug absorption ruler
- Those who have following diseases
- Patients with hypersensitivity to the ingredient of an investigational drug or to biguanide drugs
- Patients with moderate and severe renal impairment, end-stage renal disease or dialysis
- Patients with acute conditions that may affect renal function
- Patients with acute or chronic metabolic acidosis and patients with a history of ketoacidosis
- Diabetic precoma patient
- Patients with acute and unstable heart failure
- Patients receiving tests using intravenous radioactive iodine contrast material
- Patients with severe infections or severe traumatic systemic disorders
- Patients scheduled for surgery
- Patients with malnutrition, starvation, weakness, pituitary dysfunction, or adrenal dysfunction
- Patients with gastrointestinal disorders
- A history of clinically significant psychiatric disease
- Those who are judged by the investigator for reason other than the above selection/exclusion criteria and are judged unsuitable for participation in the study
- Woman who are suspected of being pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study to Evaluate the Food Effect on the Pharmacokinetics and Safety of CKD-378 in Healthy Volunteers
A clinical trial to evaluate the food effect of CKD-378
Read the detailed description
An open-label, randomized, single-dose, 2-sequence, 2-period, crossover, phase 1 study to evaluate the food effect on the pharmacokinetics and safety of CKD-378 in healthy volunteers
- Conditions
- Type II Diabetes Mellitus
- Being tested
- CKD-378, QD, PO
- 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-378, QD, PODrug
CKD-378, QD, PO
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | * Period 1: A single oral dose of 2 tablets(CKD-378) under fasting condition
* Period 2: A single oral dose of 2 tablets(CKD-378) under fed condition Receives: Drug: CKD-378, QD, PO |
| Sequence 2 | Experimental | * Period 1: A single oral dose of 2 tablets(CKD-378) under fed condition
* Period 2: A single oral dose of 2 tablets(CKD-378) under fasting condition Receives: Drug: CKD-378, QD, PO |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-378
Area under the concentration-time curve time zero to time
Measured: Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32, 48 hours
Cmax of CKD-378
Maximum plasma concentration of the drug
Measured: Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start3 May 2024
- Primary completion3 Jun 2024
- Study completion13 Jun 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
- 31 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
- NCT06386328
- Sponsor's protocol ID
- A129_03FDI2317
- Status last verified
- May 2024
- First submitted
- 23 Apr 2024
- Last updated
- 8 Jul 2024
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study to Evaluate the Food Effect on the Pharmacokinetics and Safety of CKD-378 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06386328
- Acronym / sponsor ID
- A129_03FDI2317
- Conditions
- Type II Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 3 May 2024 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 26 Apr 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-378
Detailed description
An open-label, randomized, single-dose, 2-sequence, 2-period, crossover, phase 1 study to evaluate the food effect on the pharmacokinetics and safety of CKD-378 in healthy 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-378, QD, PO* Period 1: A single oral dose of 2 tablets(CKD-378) under fasting condition * Period 2: A single oral dose of 2 tablets(CKD-378) under fed condition |
| Sequence 2 | Experimental | Drug: CKD-378, QD, PO* Period 1: A single oral dose of 2 tablets(CKD-378) under fed condition * Period 2: A single oral dose of 2 tablets(CKD-378) under fasting condition |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adult aged ≥ 19 at screening
- Body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0kg/m2 and Body weight ≥ 50kg
- Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination
- A person who is deemed suitable as a subject as a result of screening such as clinical laboratory examination (hematology, blood chemistry, serological tests, urinalysis, etc.), electrocardiogram examination, etc.
- A person who has received a sufficient explanation of the purpose and contents of the clinical trial and has agreed in writing voluntarily to participate in the clinical trial
Key exclusion criteria (22 listed)
- Those who have taken a drug known to significantly induce or inhibit drug metabolizing enzymes within 30 days before the first administration of investigational product, or who have taken drug that may interfere with this investigational product within 10 days
- Those with a history of regular alcohol intake before the first administration of investigational product
- Those who have taken other investigational product within 6 months before the first administration of the investigational product
- Those who have donated whole blood within 8 weeks or donated component blood within 2 weeks or received blood transfusion within 4 weeks before the first administration of the investigational product
- Those with a history of gastrointestinal diseases or surgery (except simple appendicectomy, hernia surgery) that may affect drug absorption ruler
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-378, QD, POCKD-378, QD, PO | Drug | Sequence 1, Sequence 2 |
Primary outcome
AUCt of CKD-378
Time frame: Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32, 48 hours
Area under the concentration-time curve time zero to time
Cmax of CKD-378
Time frame: Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32, 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 8 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Type II Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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-378, QD, PO 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 6 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 8 Jul 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-378 (time frame: Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32, 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 8 Jul 2024.