Type II DiabetesPhase 1CKD-378NCT05881213
Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150, D029 in Healthy Adults
A Phase 1 study testing CKD-378 (low-dose) in people with Type II Diabetes, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-378 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
- What is being tested?
- CKD-378 (low-dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2023to 10 Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged between 19 and 55 years at screening.
- Those whose body weight 55 kg or over for men and 50 kg or over for women.
- Those with body mass index (BMI) was more than 18.5 kg/m2 and less than 27.0 kg/m2.
- ※ BMI (kg/m2) = body weight (kg)/ [height (m)]2
- If women, those who met any one of the following criteria.
- Menopause (no natural menstruation for at least 2 years)
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- Surgical infertility (hysterectomy or bilateral oophorectomy, tubal ligation, or infertility by other methods)
- Male subjects with female sexual partners of childbearing potential must agree to use methods of birth control (using condom) and not donate sperm during the study and for up to 28 days after the last administration of the IP (unless the male subjects or their female partners are infertile).
- Subjects who have voluntarily given written informed consent to participate in the study and comply with all study requirements after getting a detailed explanation and full understanding of the study.
Who cannot join
- Subjects with history or current conditions of clinically significant disease, including hepatobiliary (e.g., severe hepatic dysfunction, etc.), renal (e.g., severe renal insufficiency, etc.), nervous, immune, respiratory (e.g., bronchial asthma) urinary, gastrointestinal, endocrine (e.g., patients with diabetic ketoacidosis, diabetic coma and pre-coma, and type 1 diabetes mellitus, etc.), hemato-oncology, or cardiovascular (e.g., heart failure, etc.) or psychiatric disorders.
- Subjects who are susceptible to dehydration due to inadequate oral intake or who have clinically significant dehydration.
- Subjects who underwent a test using intravenous administration of radioiodine contrast media (e.g., intravenous urography, venous cholangiography, angiography, or computed tomography using a contrast medium) within 48 hours prior to the first IP administration.
- Subjects with a history or current conditions of serious urinary tract infection.
- Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Subjects with a history of gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of IP.
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- Subjects with a history of clinically significant hypersensitivity to drugs, including components of the IPs (empagliflozin or metformin) or additives.
- Subjects who were deemed unfit for participation in this study based on the following findings in the screening tests performed within 28 days before the first IP administration.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values > 1.25 times the upper limit of normal range.
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 when calculated with the modification of diet in renal disease (MDRD) formula.
- Positive result for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis infection test.
- Systolic blood pressure > 150 mmHg or <90 mmHg, or diastolic blood pressure > 100 mmHg or <50 mmHg which is measured in sitting position after resting for more than 5 minutes.
- Subjects with a history of drug abuse within a year prior to screening or positive results in urine drug screening tests.
- Women who are pregnant or breast-feeding.
- Subjects who took the following drugs, excluding the topical agents without significant systemic absorption, within the predefined period the investigator judges they could affect the results of the study or compromise the safety of the subject.
- Any prescription drugs and herbal medicines within 14 days before the first IP administration.
- Any over-the-counter drugs including health care foods or vitamins within 7 days before the first IP administration
- Any drugs administered by depot injection or other implantation into the body within 30 days before the first IP administration
- Subjects who took any drugs that induce or inhibit drug metabolizing enzymes, such as barbital drugs, within 30 days before the first IP administration.
- Subjects with excessive smoking (>10 cigarette/day), caffeine intake (caffeine:>5 cups/day), or drinking (alcohol: >210 g/week) or who cannot stop from smoking, caffeine intake, and drinking during the hospitalization period.
- Subjects who have consumed foods containing grapefruit within 7 days prior to the first IP administration or cannot stop consuming foods containing grapefruit during the study.
- Subjects who were administered any other IPs by participating in other clinical trials within 180 days before the first IP administration (in the case of biological agent, taking account of its half-life, this period can be extended).
- Subjects who donated whole blood within 60 days or blood components for apheresis within 30 days before the first IP administration.
- Subjects who received blood transfusion within 30 days before the first IP administration.
- Subjects judged by the investigators unsuitable for participating in the study based on any other reasons.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University College of Medicine
Seoul
About this study
Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150, D029 in Healthy Adults
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-378
Read the detailed description
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety after Oral Administration of CKD-378 and Co-administration of D745, D150, D029 in Healthy Adults
- Conditions
- Type II Diabetes
- Being tested
- CKD-378 (low-dose)
- 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 (low-dose)Drug
Quaque day (QD), PO
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | * Period 1: D745, D150, D029 - A single oral dose of 3tablets under food intake condition
* Period 2: CKD-378 (low-dose) - A single oral dose of 1tablet under food intake condition Receives: Drug: CKD-378 (low-dose) |
| Sequence 2 | Experimental | * Period 1: CKD-378 (low-dose) - A single oral dose of 1tablet under food intake condition
* Period 2: D745, D150, D029 - A single oral dose of 3tablets under food intake condition Receives: Drug: CKD-378 (low-dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve (AUC)t of CKD-378
Area under the concentration-time curve time zero to time
Measured: Pre-dose(0 hour) to 48 hours
Cmax of CKD-378
Maximum plasma concentration of the drug
Measured: Pre-dose(0 hour) to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jun 2023
- Primary completion28 Jun 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II 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
- 23 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
- NCT05881213
- Sponsor's protocol ID
- A129_02BE2227
- Acronym
- CKD-378
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- 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 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150, D029 in Healthy Adults
- ClinicalTrials.gov ID
- NCT05881213
- Acronym / sponsor ID
- CKD-378 / A129_02BE2227
- Conditions
- Type II Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 31 May 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 clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-378
Detailed description
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety after Oral Administration of CKD-378 and Co-administration of D745, D150, D029 in Healthy Adults
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 (low-dose)* Period 1: D745, D150, D029 - A single oral dose of 3tablets under food intake condition * Period 2: CKD-378 (low-dose) - A single oral dose of 1tablet under food intake condition |
| Sequence 2 | Experimental | Drug: CKD-378 (low-dose)* Period 1: CKD-378 (low-dose) - A single oral dose of 1tablet under food intake condition * Period 2: D745, D150, D029 - A single oral dose of 3tablets under food intake condition |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy adults aged between 19 and 55 years at screening.
- Those whose body weight 55 kg or over for men and 50 kg or over for women.
- Those with body mass index (BMI) was more than 18.5 kg/m2 and less than 27.0 kg/m2.
- ※ BMI (kg/m2) = body weight (kg)/ [height (m)]2
- If women, those who met any one of the following criteria.
Key exclusion criteria (25 listed)
- Subjects with history or current conditions of clinically significant disease, including hepatobiliary (e.g., severe hepatic dysfunction, etc.), renal (e.g., severe renal insufficiency, etc.), nervous, immune, respiratory (e.g., bronchial asthma) urinary, gastrointestinal, endocrine (e.g., patients with diabetic ketoacidosis, diabetic coma and pre-coma, and type 1 diabetes mellitus, etc.), hemato-oncology, or cardiovascular (e.g., heart failure, etc.) or psychiatric disorders.
- Subjects who are susceptible to dehydration due to inadequate oral intake or who have clinically significant dehydration.
- Subjects who underwent a test using intravenous administration of radioiodine contrast media (e.g., intravenous urography, venous cholangiography, angiography, or computed tomography using a contrast medium) within 48 hours prior to the first IP administration.
- Subjects with a history or current conditions of serious urinary tract infection.
- Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
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 (low-dose)Quaque day (QD), PO | Drug | Sequence 1, Sequence 2 |
Primary outcome
area under the curve (AUC)t of CKD-378
Time frame: Pre-dose(0 hour) to 48 hours
Area under the concentration-time curve time zero to time
Cmax of CKD-378
Time frame: Pre-dose(0 hour) to 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 19 Dec 2023.
- Individual participant dataSharing planned: No
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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-378 (low-dose) in people with Type II 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 9 inclusion and 25 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 19 Dec 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?
area under the curve (AUC)t of CKD-378 (time frame: Pre-dose(0 hour) to 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 19 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.