AzTrials
AzTrials

Type II Diabetes MellitusPhase 1NCT05274880

Study to Evaluate the Food Effect on Pharmacokinetics Profile and Safety of CKD-393

A Phase 1 study testing CKD-393 in people with Type II Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Study to evaluate the food effect on pharmacokinetic profiles and safety of CKD-393 in healthy volunteers Read more about this study

Who is it for?
Ages 19 to 54 yearsHealthy volunteers can take part
Conditions the study is for
Type II Diabetes Mellitus
What is being tested?
CKD-393
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteSouth Korea
Study dates
21 Jun 2022to 26 Jul 2022
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 54 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults aged 19 years old or more and less than 55 years old at screening
  • Individuals who had 17.5 kg/m2 ≤ Body mass index (BMI) < 30.5 kg/m2 and body weight ≥ 55 kg for males and body weight ≥ 50 kg for females
  • ☞ BMI = Body weight (kg) / height (m)2
  • Individuals without congenital disease, chronic disease within the last 3 years, or pathological symptoms or signs based on medical examination
  • Individuals who were deemed to be eligible based on the screening tests such as laboratory tests (hematology, chemistry, urinalysis, serology, etc.), vital signs, and 12-lead electrocardiogram
  • Individuals who were willing to participate in the study after being fully informed of the study object and procedures and who signed an informed consent form approved by the institutional review board (IRB) of Korea University Guro Hospital
  • Individuals who agreed to use appropriate contraceptive methods (contraceptive methods other than hormones: condoms, intrauterine devices (IUD, IUS), tubal ligation, cervical cap, diaphragm, etc.) and agreed not to donate sperm during the clinical study and until 1 month after the last administration of investigational product
  • Individuals with the ability and willingness to participate the entire study

Who cannot join

  • Individuals with medical evidence or clinically significant history of hematological, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic, or immune disease (excluding simple dental histories of dental plaque, impacted tooth, or wisdom tooth, etc.) 1-1) Patients with severe heart failure or who had history of heart failure (New York Heart Association (NYHA) class 1, 2, 3, 4) 1-2) Patients with hepatic failure 1-3) Patients with diabetic ketoacidosis, diabetic coma, or type 1 diabetes mellitus 1-4) Patients with severe infection or trauma, or pre-/post-operative patients 1-5) Patients with edema 1-6) Patients with moderate to severe kidney impairment (eGFR<60 mL/min/1.73 m2) 1-7) Patients who had acute condition that affects renal function such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, or sepsis 1-8) Patients who underwent tests using intravenous radioactive iodine contrast (e.g., intravenous urography, intravenous cholangiography, angiography, contrast enhanced computed tomography, etc.) 1-9) Patients with malnutrition, starvation, asthenia, pituitary insufficiency, or adrenal insufficiency 1-10) Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • Individuals with a history of gastrointestinal disease (e.g., esophageal achalasia, esophagostenosis, or Crohn's disease) or surgery (excluding simple appendectomy, hernia repair, or tooth extraction) that might affect drug absorption
  • Individuals who had following laboratory test results at screening:
  • ☞ ALT or AST > 2x the upper limit of the normal range
  • Individuals who had regular alcohol consumption exceeding 210 g /week within 6 months prior to screening (Beer (5%) 250 mL = 10 g, Soju (20%) 50 mL = 8 g, wine (12%) 125 mL = 12 g)
  • Individuals who smoked 20 cigarettes or more per day within 6 months prior to screening
Show all 18Show fewer
  • Individuals who had taken any investigational product from other clinical or bioequivalence studies within 6 months prior to the first administration of the investigational product of this study
  • Individuals who had following vital signs at screening:
  • ☞ Sitting systolic blood pressure < 90 mmHg or ≥ 160 mmHg or sitting diastolic blood pressure < 60 mmHg or ≥ 100 mmHg
  • Individuals who had serious alcohol or drug abuse history within 1 year prior to the screening
  • Individuals who had taken any drug known as a strong inducer or inhibitor of drug metabolizing enzymes within 30 days prior to the first administration of the investigational product
  • Individuals who had taken prescribed or over-the-counter medicine within 10 days prior to the first administration of the investigational product
  • Individuals who had donated whole blood within 2 months or blood components within 1 month prior to the first administration of the investigational product, or who received transfusion within 1 month prior to the first administration of the investigational product
  • Individuals who had severe acute/chronic medical or mental conditions that might increase the risk caused by study participation or administration of the investigational product or might interfere with the interpretation of study results
  • Individuals with hypersensitivity or history of allergy to the investigational product as well as main ingredients and components of the investigational product (such as tartrazine and sunset yellow FCF)
  • Women who were or might be pregnant and who were breastfeeding
  • Individuals who could not consume the high-fat meal provided during the clinical study
  • Individuals judged by the investigator as inappropriate to participate in the study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Guro Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-393 in Healthy Volunteers

Study to evaluate the food effect on pharmacokinetic profiles and safety of CKD-393 in healthy volunteers

Read the detailed description

A randomized, open-label, single dose, crossover study to evaluate the food effect on pharmacokinetic profiles and safety of CKD-393 in healthy volunteers

Being tested
CKD-393
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-393Drug

    PO, QD

Study groups in NCT05274880
Study groupRoleWhat they receive
Sequence 1ExperimentalPeriod 1: CKD-393 administration after a high-fat meal/ Period 2: CKD-393 administration at fasting state
Receives: Drug: CKD-393
Sequence 2ExperimentalPeriod 1: CKD-393 administration at fasting state/ Period 2: CKD-393 administration after a high-fat meal
Receives: Drug: CKD-393

What is being measured

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

  1. AUCt of CKD-393

    AUCt: Area under the curve from dosing to time

    Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours

  2. Cmax of CKD-393

    Cmax: Peak plasma drug concentration

    Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 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 posted11 Mar 2022
  2. Study start21 Jun 2022
  3. Primary completion15 Jul 2022
  4. Study completion26 Jul 2022

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
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05274880
Sponsor's protocol ID
A98_06FDI2125
Status last verified
Mar 2022
First submitted
2 Mar 2022
Last updated
30 Nov 2022
Results posted
No
Data monitoring committee
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-393 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 8 inclusion and 18 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 30 Nov 2022. 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?

AUCt of CKD-393 (time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 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 NCT05274880.

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 30 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in