Type II Diabetes MellitusPhase 1NCT05952219
Study to Evaluate the Safety and Pharmacokinetics of CKD-379
A Phase 1 study testing CKD-379 and D759+D745+D029+D150 in people with Type II Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- CKD-379 and D759+D745+D029+D150
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jun 2023to 30 Oct 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 19 aged and 50 aged in healthy adult
- 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2 and 50.0kg≤Body weight≤90.0kg
Who cannot join
- Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system
- Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
- Those who are pregnant or breastfeeding
- 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-379 in Healthy Volunteers Under Fed Conditions
A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination
Read the detailed description
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-379 in healthy volunteers under fed conditions
- Conditions
- Type II Diabetes Mellitus
- Being tested
- CKD-379, D759+D745+D029+D150
- 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
2 tablet administration under fed condition
D759+D745+D029+D150Drug
4 tablet co-administration under fed condition
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1: Reference drug(D759+D745+D029+D150) Period 2: Test drug(CKD-379) Receives: Drug: CKD-379; Drug: D759+D745+D029+D150 |
| Sequence 2 | Experimental | Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D029+D150) Receives: Drug: CKD-379; Drug: D759+D745+D029+D150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Maximum plasma concentration of the drug
Measured: 0~48hours
Cmax
Area under the concentration-time curve from the time of dosing to the last measurable concentration
Measured: 0~48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start2 Jun 2023
- Primary completion19 Jun 2023
- Study completion30 Oct 2023 (estimated)
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seol Ju Moon, M.D, Ph.D., Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952219
- Sponsor's protocol ID
- A125_04BE2302
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 19 Jul 2023
- 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 19 Jul 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-379 in Healthy Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT05952219
- Acronym / sponsor ID
- A125_04BE2302
- Conditions
- Type II Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 19 Jul 2023 (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 study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination
Detailed description
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-379 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 |
|---|---|---|
| Sequence 1 | Experimental | Drug: CKD-379, Drug: D759+D745+D029+D150Period 1: Reference drug(D759+D745+D029+D150) Period 2: Test drug(CKD-379) |
| Sequence 2 | Experimental | Drug: CKD-379, Drug: D759+D745+D029+D150Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D029+D150) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between 19 aged and 50 aged in healthy adult
- 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2 and 50.0kg≤Body weight≤90.0kg
Key exclusion criteria (4 listed)
- Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system
- Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
- Those who are pregnant or breastfeeding
- Those who are deemed inappropriate to participate in clinical trial by investigators
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-3792 tablet administration under fed condition | Drug | Sequence 1, Sequence 2 |
| D759+D745+D029+D1504 tablet co-administration under fed condition | Drug | Sequence 1, Sequence 2 |
Primary outcome
AUCt
Time frame: 0~48hours
Maximum plasma concentration of the drug
Cmax
Time frame: 0~48hours
Area under the concentration-time curve from the time of dosing to the last measurable concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 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.
Seol Ju Moon, 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-379 and D759+D745+D029+D150 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 2 inclusion and 4 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 19 Jul 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?
Results are not available in the source record.
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 (time frame: 0~48hours). 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 19 Jul 2023.