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Type2 Diabetes MellitusPhase 1NCT04221360

A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-375

A Phase 1 study testing CKD-375 and D390 in people with Type2 Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-375. 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-375 and D390
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteSouth Korea
Study dates
29 Jan 2020to 8 Jun 2020
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, hemato-oncology, cardiovascular systemic disease or psychosis disorder
  • Subjects who has clinically significant dehydration or is vulnerable to dehydration due to poor oral intake
  • Subjects who underwent intravenous administration of radioactive iodine contrast agents (e.g., intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48 hours prior to the first dose of the investigational product
  • Subjects who have a significant urinary tract infection or have such a history
  • Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • 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
Show all 23Show fewer
  • Subjects who have a history of clinically significant hypersensitivity to drugs or additives, including components of the investigational product (empagliflozin, metformin)
  • 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
  • Total bilirubin > UNL(Upper Normal Limit)x1.5
  • eGFR (Estimated Glomerular Filtration Rate) <60 mL / min / 1.73m2 using the MDRD (Modification of Diet in Renal Disease) formula
  • 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
  • Pregnant or lactating women
  • 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 took any of the following drugs except for topical without serious systemic absorption and hormonal contraceptives and are deemed that the administered drug may affect in the study or the safety of the subject by the investigator
  • 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
  • Drugs administered by depot injection or through iomplantation in the human body within 30 days of the first dose of investigational product
  • 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 were deemed to be inappropriate to participate in the study by the investigator judgment

Trial locations and contacts

1 site in 1 country.

Min Soo Park, M.D., Ph.D. contact

+82-2-2228-0401

minspark@yuhs.ac

South Korea1 site

  • Yonsei University Severance Hospital

    Soeul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of High Dose CKD-375 and D390 in Healthy Adults.

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-375.

Read the detailed description

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of High Dose CKD-375 and D390 in Healthy Adults.

Being tested
CKD-375, D390

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CKD-375Drug

    Test drug, QD, PO

  • D390Drug

    Reference drug, QD, PO

Study groups in NCT04221360
Study groupRoleWhat they receive
Group 1Experimental* Period 1: D390 * Period 2: CKD-375
Receives: Drug: CKD-375; Drug: D390
Group 2Experimental* Period 1: CKD-375 * Period 2: D390
Receives: Drug: CKD-375; Drug: D390

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of D390 and CKD-375

    Maximum plasma concentration of D390 and CKD-375

    Measured: 0(predose)~48 hours

  2. AUClast of D390 and CKD-375

    Area under the plasma concentration-time curve to last concentration of D390 and CKD-375

    Measured: 0(predose)~48 hours

Secondary outcomes (5)

  1. AUCinf of D390 and CKD-375

    Area under the plasma concentration-time curve from zero to infinity concentration of D390 and CKD-375

    Measured: 0(predose)~48 hours

  2. Tmax of D390 and CKD-375

    Time to maximum plasma concentration of D390 and CKD-375

    Measured: 0(predose)~48 hours

  3. t1/2 of D390 and CKD-375

    Half-life of D390 and CKD-375

    Measured: 0(predose)~48 hours

  4. Vd/F of D390 and CKD-375

    Apparent volume of distribution of D390 and CKD-375

    Measured: 0(predose)~48 hours

  5. CL/F of D390 and CKD-375

    Apparent clearance of D390 and CKD-375

    Measured: 0(predose)~48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2020
  2. Study start29 Jan 2020 (estimated)
  3. Primary completion6 Mar 2020 (estimated)
  4. Study completion8 Jun 2020 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04221360
Sponsor's protocol ID
A92_02BE1920
Status last verified
Jan 2020
First submitted
6 Jan 2020
Last updated
9 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-375 and D390 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 6 inclusion and 23 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 9 Jan 2020. 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 Min Soo Park, M.D., Ph.D. (+82-2-2228-0401, minspark@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of D390 and CKD-375 (time frame: 0(predose)~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?

On the ClinicalTrials.gov record for NCT04221360.

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 9 Jan 2020.

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