T2DM (Type 2 Diabetes Mellitus)Phase 1NCT04706286
Clinical Trial to Investigate the Pharmacokinetics and Safety of CKD-393
A Phase 1 study testing CKD-501, D759, D150 and CKD-393 0.5/100/1000 mg in people with T2DM (Type 2 Diabetes Mellitus), run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-393 0.5/100/1000 mg under fed condition Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- CKD-501, D759, D150 and CKD-393 0.5/100/1000 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Feb 2021to 5 Apr 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 who is 19 ~ 55 years at the time of screening
- Body weight more than 55 kg for male and more than 50kg for female
- BMI more than 18.5 kg/m2 or less than 27.0 kg/m2
- Females must be menopause or surgical infertility
- Males who have consented to the use of appropriate pregnancy contraceptive methods up to 28 days after the last investigational product and not to provide sperm
- Subjects who voluntarily decided to participate and informed consent based upon understanding on the study.
Who cannot join
- Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hematooncology, cardiovascular systemic disease or psychosis disorder
- Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subjects with poor oral intake, susceptible to dehydration or clinically significant dehydration
- Subjects who have a history of gastrointestinal disorders (Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the drug
- Subjects who have a history of clinically significant hypersensitivity to drugs or additives
- Subjects who have severe infectious disease and severe trauma before and after operation
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- Subjects who have undergone i.v. testing of radioactive iodine contrast material within 48 hours before the first IP administration
- Subjects who are deemed unsuitable as subjects in the screening test performed within 28 days before the administration of investigational product
- AST, ALT> UNL(Upper Normal Limit)x1.25
- eGFR (Estimated Glomerular Filtration Rate) <60 mL/min/1.73m2 using the MDRD (Modification of Diet in Renal Disease) equation
- Positive immunologic serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
- After resting for more than 5 minutes, systolic blood pressure> 150 mmHg or < 90 mmHg, diastolic blood pressure> 100 mmHg or <50 mmHg
- Subjects who have had a history of drug abuse within one year of screening or have tested positive on urine drug screening test
- Subjects who judged to able to affect in the study or in the subject's safety by the investigator for the following reasons
- Ethical-the-counter (ETC) drugs and herbal medicines within 14 days of the first administration of the investigational drug.
- Over-the-counter (OTC) drugs, including health foods and vitamin preparations, within 7 days of the first dose of the investigational product
- Inducing or inhibiting drugs of drug-metabolism enzyme, within 30 days of the first dose of the investigational product
- Subjects who have consistently excessively smoked or consumed caffeine or alcohol (caffeine:> 5 cups / day, alcohol:> 210 g / week, cigarettes:> 10 cigarettes / day) or cannot stop smoking, consuming caffeine and alcohol during hospitalization
- Subjects who take grapefruit-containing food within 7 days before IP administration, or cannot forbid taking grapefruit-containing food for period of clinical trials.
- Subjects who have received the investigational product by participating in other clinical trials (including bioequivalence studies) within 180 days before the first dose of the investigational product (For biological agents, this may be based on a longer period of time, considering the half-life)
- Subjects who donated whole blood within 60 days before the first dose of the investigational product or donated component blood donation within 30 days
- Subjects who received a blood transfusion within 30 days before the first dose of the investigational product
- Pregnant or lactating women
- Subjects who were deemed to be inappropriate to participate in the study by the investigator judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety of CKD-393 and Co-administration of CKD-501, D759 and D150 Under Fed Condition in Healthy Adults
A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-393 0.5/100/1000 mg under fed condition
Read the detailed description
A Phase 1 Clinical Trial to evaluate the safety and pharmacokinetics in healthy adult volunteers after administration of CKD-393 0.5/100/1000 mg under fed condition.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- CKD-501, D759, D150, CKD-393 0.5/100/1000 mg
- 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-501, D759, D150Drug
Also called Treatment A
CKD-501 0.5 mg 1T, D759 100 mg 1T and D150 1000 mg 1T, single oral administration under fed condition
CKD-393 0.5/100/1000 mgDrug
Also called Treatment B
CKD-393 0.5/100/1000 mg 1T, single oral administration under fed condition
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 1. Period 1: Treatment A
2. Period 2: Treatment B Receives: Drug: CKD-501, D759, D150; Drug: CKD-393 0.5/100/1000 mg |
| Group 2 | Experimental | 1. Period 1: Treatment B
2. Period 2: Treatment A Receives: Drug: CKD-501, D759, D150; Drug: CKD-393 0.5/100/1000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt(Area Under Curve last) of CKD-393
Area under the plasma concentration time curve of CKD-393, from time zero up to the last measurable concentration.
Measured: From predose, upto 48 hours post-dose
Cmax of CKD-393
The maximum concentration observed of CKD-393 over blood sampling time.
Measured: From predose, upto 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start18 Feb 2021 (estimated)
- Primary completion29 Mar 2021 (estimated)
- Study completion5 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Choon Ok Kim, M.D., Ph.D., Principal investigator, Severance hospital of the Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706286
- Sponsor's protocol ID
- A98_03BE2018
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 12 Jan 2021
- 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 12 Jan 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 of CKD-393 and Co-administration of CKD-501, D759 and D150 Under Fed Condition in Healthy Adults
- ClinicalTrials.gov ID
- NCT04706286
- Acronym / sponsor ID
- A98_03BE2018
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2021 (estimated)
- Primary completion
- 29 Mar 2021 (estimated)
- Study completion
- 5 Apr 2021 (estimated)
- First posted
- 12 Jan 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 Pharmacokinetics and safety of CKD-393 0.5/100/1000 mg under fed condition
Detailed description
A Phase 1 Clinical Trial to evaluate the safety and pharmacokinetics in healthy adult volunteers after administration of CKD-393 0.5/100/1000 mg under fed condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: CKD-501, D759, D150, Drug: CKD-393 0.5/100/1000 mg1. Period 1: Treatment A 2. Period 2: Treatment B |
| Group 2 | Experimental | Drug: CKD-501, D759, D150, Drug: CKD-393 0.5/100/1000 mg1. Period 1: Treatment B 2. Period 2: Treatment A |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult who is 19 ~ 55 years at the time of screening
- Body weight more than 55 kg for male and more than 50kg for female
- BMI more than 18.5 kg/m2 or less than 27.0 kg/m2
- Females must be menopause or surgical infertility
- Males who have consented to the use of appropriate pregnancy contraceptive methods up to 28 days after the last investigational product and not to provide sperm
Key exclusion criteria (24 listed)
- Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hematooncology, cardiovascular systemic disease or psychosis disorder
- Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subjects with poor oral intake, susceptible to dehydration or clinically significant dehydration
- Subjects who have a history of gastrointestinal disorders (Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the drug
- Subjects who have a history of clinically significant hypersensitivity to drugs or additives
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, D759, D150Also: Treatment ACKD-501 0.5 mg 1T, D759 100 mg 1T and D150 1000 mg 1T, single oral administration under fed condition | Drug | Group 1, Group 2 |
| CKD-393 0.5/100/1000 mgAlso: Treatment BCKD-393 0.5/100/1000 mg 1T, single oral administration under fed condition | Drug | Group 1, Group 2 |
Primary outcome
AUCt(Area Under Curve last) of CKD-393
Time frame: From predose, upto 48 hours post-dose
Area under the plasma concentration time curve of CKD-393, from time zero up to the last measurable concentration.
Cmax of CKD-393
Time frame: From predose, upto 48 hours post-dose
The maximum concentration observed of CKD-393 over blood sampling time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- 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.
Choon Ok Kim, M.D., Ph.D. principal investigator
Severance hospital of the Yonsei University
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, D759, D150 and CKD-393 0.5/100/1000 mg in people with T2DM (Type 2 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 24 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 12 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Choon Ok Kim, M.D., Ph.D. (+82-2-2228-0455, DELIVERY98@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt(Area Under Curve last) of CKD-393 (time frame: From predose, upto 48 hours post-dose). 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 12 Jan 2021.