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Type 2 Diabetes MellitusPhase 1NCT04869800

Evaluate the Drug-drugs Interaction Between Lobeglitazone 0.5mg and Empagliflozin 25mg

A Phase 1 study testing CKD-398 and CKD-501, D745 in people with Type 2 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
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Trial summary

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-398 Read more about this study

Who is it for?
Ages 19 to 54 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
CKD-398 and CKD-501, D745
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSouth Korea
Study dates
27 May 2021to 15 Jun 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 54 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults age≥19 years and age<55 years at the time of screening
  • Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg
  • BMI = Weight(kg)/ Height(m)2
  • Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
  • Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/ bacterial, etc.) and vital signs, ECG etc. performed at screening
  • Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational product
  • Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
  • Individuals with the ability and willingness to participate the entire study period

Who cannot join

  • Individuals with a medical evidence or a history (excluding a dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune diseases.
  • Individuals with a medical history of gastrointestinal disease (e.g., gullet disease such as esophageal achalasia and esophagostenosis and Crohn's disease) or operations (excluding simple appendectomy, herniotomy or tooth extraction) that may affect drug absorption.
  • Individuals with the following laboratory test results at screening:
  • ALT or AST > 2x the upper limit of the normal range
  • History of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
  • Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening
Show all 24Show fewer
  • Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
  • Following vital signs results at screening
  • Sitting systolic blood pressure ≥ 140 mmHg or < 90 mmHg and/or sitting diastolic blood pressure ≥90 mmHg or <60 mmHg
  • Individuals with a medical history of significant alcohol or drug abuse within one year prior to the screening
  • Individuals who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first dose of investigational product(s)
  • Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
  • Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)
  • Individuals with severe acute/chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results
  • Individuals with hypersensitivity to investigational products or the investigational products ingredients or dihydropyridine drugs
  • Subject had severe heart failure(NYHA class 1, 2, 3, 4)
  • Patients with hepatopathy
  • Patients with diabetic ketogenic acidosis, diabetic comas and ex-coma, type 1 diabetes.
  • Before and after surgery, severe infections, severe trauma.
  • Patients with edema
  • Subject had renal impairment(eGFR < 60 mL/min/1.73 m²)
  • Subject who is a pregnant or nursing woman
  • Subject had genetic dysfunctions like galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Subjects who were deemed inappropriate to participate in the study by the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chonbuk National University Hospital

    Jeonju

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-398 in Healthy Volunteers Under Fasting Conditions

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-398

Read the detailed description

A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-398 in healthy volunteers under fasting conditions

Being tested
CKD-398, CKD-501, D745
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-398Drug

    Test Drug

  • CKD-501, D745Drug

    Reference Drug

Study groups in NCT04869800
Study groupRoleWhat they receive
Sequence 1Experimental1. Period 1: Reference drug(CKD-501, D745) 2. Period 2: Test drug(CKD-398)
Receives: Drug: CKD-398; Drug: CKD-501, D745
Sequence 2Experimental1. Period 1: Test drug(CKD-398) 2. Period 2: Reference drug(CKD-501, D745)
Receives: Drug: CKD-398; Drug: CKD-501, D745

What is being measured

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

  1. AUCt of CKD-398

    Area under the plasma concentration time curve of CKD-344, from time zero up to the last measurable concentration.

    Measured: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose

  2. Cmax of CKD-398

    The maximum concentration observed of CKD-344 over blood sampling time.

    Measured: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose

Secondary outcomes (5)

  1. AUCinf of CKD-398

    Area under the concentration-time curve from zero up to ∞

    Measured: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose

  2. Tmax of CKD-398

    Time to maximum plasma concentration

    Measured: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose

  3. T1/2 of CKD-398

    Terminal elimination half-life

    Measured: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose

  4. CL/F of CKD-398

    Apparent Clearance

    Measured: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose

  5. Vd/F of CKD-398

    Apparent volume of distribution

    Measured: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 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.

  1. First posted3 May 2021
  2. Study start27 May 2021
  3. Primary completion7 Jun 2021
  4. Study completion15 Jun 2021

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04869800
Sponsor's protocol ID
A113_01BE2103
Status last verified
Aug 2021
First submitted
28 Apr 2021
Last updated
25 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-398 and CKD-501, D745 in people with 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 8 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: finished, as of the sponsor's last update on 25 Aug 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?

AUCt of CKD-398 (time frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 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?

On the ClinicalTrials.gov record for NCT04869800.

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 25 Aug 2021.

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