Type2 Diabetes MellitusPhase 1NCT04810676
A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-383.
A Phase 1 study testing CKD-501, D745, D150 and CKD-383 in people with Type2 Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A clinical trial to evaluate the pharmacokinetic profiles and safety of CKD-383. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- CKD-501, D745, D150 and CKD-383
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Apr 2021to 26 May 2021
- 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 volunteers aged between 19 and 55 years old.
- Weight ≥ 55kg(men) or ≥50kg(women),
- Calculated body mass index(BMI) of 18.5 to 27.0kg/m2
- Body Mass Index(BMI) = Weight(kg) / [Height(m)]2
- Women must meet one of the criteria written in below:
- Menopause (No menstruation for 2 years)
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- Sterilization (hysterectomy or Oophorectomy, Tubal ligation etc.)
- Men agree to contraception and not to donate sperm during the participation of clinical trial.
- Those who voluntarily decide to participate and agree to comply with the cautions after fully understand of the detailed description of this clinical trial.
Who cannot join
- Those who have a clinically significant disease or medical history of hepatic-biliary system issues, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Digestive system disorder, Endocrine system disorder, Cardiovascular disorder, Blood tumor and/or mental health problems.
- Those who have signs and symptoms of clinically significant dehydration or who are vulnerable to dehydration by poor oral intake.
- Those who receive intravenous administration of radioactive iodine contrast agents (for Urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48hours before the first administration of investigational product.
- Those who have severe urinary tract infection or have a past medical history of it.
- Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
- Those who have past medical history of gastrointestinal disorder(Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of drug
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- Those who have history of hypersensitivity to active pharmaceutical ingredient(Lobeglitazone, Empagliflozin, Metformin) or additives.
- Those who have the test results written in below:
- AST/ALT > 1.25 times higher than upper normal level
- eGFR(estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2
- "positive" or "reactive" test result of Hepatitis B \& C, HIV, PRP
- Under 5 min resting condition, systolic blood pressure >150mmHg or <90mmHg, Diastolic blood pressure >100mmHg, or <50mmHg
- Those who have a drug abuse history within one year or positive reaction on urine drug screening test
- Those who received following drugs, which may affect results of clinical trial and safety. Ethical-the-counter (ETC) drugs and herbal medicines within 14 days before the first administration of the investigational drug. Over-the-counter (OTC) drugs, health foods and vitamin preparations within 7 days before the first administration of the investigational product.
- Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of investigational product
- Those who exceeding an alcohol and smoke consumption criteria or can't stop smoking, consuming alcohol and caffeine during hospitalization period (Criteria: Caffeine > 5 cups/day, Alcohol > 210 g/week, Smoke > 10 cigarettes/day)
- Those who took grapefruit before the first administration of investigational product or can't stop taking grapefruit during hospitalization period
- Those who received investigational product by participating in other clinical trial within 6 months before the first administration of investigational product
- Those who donated whole blood within 2 months or apheresis within 1 month
- Those who received transfusion within 1 month
- 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.
South Korea1 site
Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu 50-1, 03722
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-383 and Co-administration of CKD-501, D745, D150 Under Fed Condition in Healthy Adults.
A clinical trial to evaluate the pharmacokinetic profiles and safety of CKD-383.
Read the detailed description
A phase 1 clinical trial to evaluate pharmacokinetics and safety in healthy adult after oral administration of CKD-383 and co-administration of CKD-501, D745, D150.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- CKD-501, D745, D150, CKD-383
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-501, D745, D150Drug
QD, PO
CKD-383Drug
QD, PO
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Peroid 1: CKD-501, D745, D150 -PO
Peroid 2: CKD-383- PO Receives: Drug: CKD-501, D745, D150; Drug: CKD-383 |
| Sequence 2 | Experimental | Peroid 1: CKD-383- PO
Peroid 2: CKD-501, D745, D150 -PO Receives: Drug: CKD-501, D745, D150; Drug: CKD-383 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of CKD-383
AUClast: Area under the concentration-time curve from time zero to the last measurable concetnration time
Measured: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Cmax of CKD-383
Cmax: Maximum plasma concentration of the drug
Measured: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Secondary outcomes (5)
AUCinf of CKD-383
AUCinf: Area under the concentration-time curve from zero up to infinity
Measured: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Tmax of CKD-383
Tmax: Time to maximum plasma concentration
Measured: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
T1/2 of CKD-383
T1/2: Terminal elimination half-life
Measured: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Vd/F of CKD-383
Vd/F: Volume of distribution
Measured: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
CL/F of CKD-383
CL/F: Clearance
Measured: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 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 posted23 Mar 2021
- Study start16 Apr 2021
- Primary completion20 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-soo Park, MD, PhD., Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810676
- Sponsor's protocol ID
- A101_02BE2020
- Status last verified
- Jun 2021
- First submitted
- 11 Mar 2021
- Last updated
- 10 Jun 2021
- 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 10 Jun 2021. 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-383 and Co-administration of CKD-501, D745, D150 Under Fed Condition in Healthy Adults.
- ClinicalTrials.gov ID
- NCT04810676
- Acronym / sponsor ID
- A101_02BE2020
- Conditions
- Type2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 23 Mar 2021 (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 pharmacokinetic profiles and safety of CKD-383.
Detailed description
A phase 1 clinical trial to evaluate pharmacokinetics and safety in healthy adult after oral administration of CKD-383 and co-administration of CKD-501, D745, D150.
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-501, D745, D150, Drug: CKD-383Peroid 1: CKD-501, D745, D150 -PO Peroid 2: CKD-383- PO |
| Sequence 2 | Experimental | Drug: CKD-501, D745, D150, Drug: CKD-383Peroid 1: CKD-383- PO Peroid 2: CKD-501, D745, D150 -PO |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy adult volunteers aged between 19 and 55 years old.
- Weight ≥ 55kg(men) or ≥50kg(women),
- Calculated body mass index(BMI) of 18.5 to 27.0kg/m2
- Women must meet one of the criteria written in below:
- Men agree to contraception and not to donate sperm during the participation of clinical trial.
Key exclusion criteria (22 listed)
- Those who have a clinically significant disease or medical history of hepatic-biliary system issues, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Digestive system disorder, Endocrine system disorder, Cardiovascular disorder, Blood tumor and/or mental health problems.
- Those who have signs and symptoms of clinically significant dehydration or who are vulnerable to dehydration by poor oral intake.
- Those who receive intravenous administration of radioactive iodine contrast agents (for Urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48hours before the first administration of investigational product.
- Those who have severe urinary tract infection or have a past medical history of it.
- Those who have genetic problems such as galactose intolerance, Lapp lactose 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-501, D745, D150QD, PO | Drug | Sequence 1, Sequence 2 |
| CKD-383QD, PO | Drug | Sequence 1, Sequence 2 |
Primary outcome
AUClast of CKD-383
Time frame: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
AUClast: Area under the concentration-time curve from time zero to the last measurable concetnration time
Cmax of CKD-383
Time frame: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Cmax: Maximum plasma concentration of the drug
5 secondary outcomes
AUCinf of CKD-383
Time frame: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Tmax of CKD-383
Time frame: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
T1/2 of CKD-383
Time frame: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Vd/F of CKD-383
Time frame: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
CL/F of CKD-383
Time frame: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
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 10 Jun 2021.
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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.
Min-soo Park, MD, PhD. principal investigator
Severance 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-501, D745, D150 and CKD-383 in people with Type2 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 9 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 10 Jun 2021. 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?
AUClast of CKD-383 (time frame: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 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 10 Jun 2021.