Endocrine, Nutritional and Metabolic DiseasesPhase 1NCT06399068
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-387 in Healthy Volunteers Under Fed Conditions
A Phase 1 study testing CKD-387 and D484 in people with Endocrine, Nutritional and Metabolic Diseases, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-387 in healthy volunteers under fed conditions Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrine, Nutritional and Metabolic Diseases
- What is being tested?
- CKD-387 and D484
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Sep 2022to 5 Oct 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults volunteers aged between 19 and 55 years old 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 Institutional Review Board of Bumin Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective and content
- 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:
- Alanine aminotransferase or Aspartate aminotransferase > 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 or consumed more than 5 cups of caffeine per day prior to first administration of investigational drugs
Show all 27Show fewer
- Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first administration of investigational drugs
- Following vital signs results at screening
- Sitting systolic blood pressure ≥ 150 mmHg or < 90 mmHg and/or sitting diastolic blood pressure ≥100 mmHg or <50 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 administration of investigational drugs
- Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first administration of investigational drugs
- Individuals who donated whole blood within the 8 weeks, or blood components within 2 weeks prior to the first administration of investigational drugs
- 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
- Patients with nephropathy (eGFR<60 ml/min/1.73 m2)
- Acute conditions that can affect renal function such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, and sepsis
- Patients with acute or chronic metabolic acidosis including type 1 diabetes mellitus, lactic acidosis, or diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis
- Diabetic precoma
- Patients undergoing intravenous administration of radioactive iodine contrast material (e.g., intravenous urography, venous cholangiography, angiography, computed tomography using contrast medium, etc.)
- Patients with congestive heart failure or heart failure who require drug treatment (NYHA class IV)
- Patients with severe infection or severe traumatic systemic disorder
- Patients with malnutrition, starvation, weakness, pituitary insufficiency or adrenal insufficiency
- Patients with genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption
- Women who are pregnant or may be pregnant
- Individuals who cannot consume the high-fat meal provided during this clinical trial
- Individuals who were deemed to be inappropriate to participate in the study by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-387 in Healthy Volunteers Under Fed Conditions
This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-387 in healthy volunteers under fed conditions
Read the detailed description
To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
- Being tested
- CKD-387, D484
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-387Drug
Also called Test
1 Tablet
D484Drug
Also called Reference
1 Tablet
| Study group | Role | What they receive |
|---|---|---|
| Reference-Test | Experimental | Not described Receives: Drug: CKD-387; Drug: D484 |
| Test- Reference | Experimental | Not described Receives: Drug: CKD-387; Drug: D484 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-387, D484
Area under the CKD-387, D484 concentration in blood-time curve from 0 to last sampling time (t)
Measured: (Pre-dose) 0 hour, (Post-dose) 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours
Cmax of CKD-387, D484
The maximum CKD-387, D484 concentration in blood sampling time (t)
Measured: (Pre-dose) 0 hour, (Post-dose) 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 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.
- First posted3 May 2024
- Study start19 Sep 2022
- Primary completion29 Sep 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine, Nutritional and Metabolic DiseasesStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399068
- Sponsor's protocol ID
- A84_09BE2208
- Status last verified
- May 2024
- First submitted
- 22 Jan 2024
- Last updated
- 3 May 2024
- Results posted
- 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 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-387 in Healthy Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT06399068
- Acronym / sponsor ID
- A84_09BE2208
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 3 May 2024 (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.
This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-387 in healthy volunteers under fed conditions
Detailed description
To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference-Test | Experimental | Drug: CKD-387, Drug: D484 |
| Test- Reference | Experimental | Drug: CKD-387, Drug: D484 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adults volunteers aged between 19 and 55 years old 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
- 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 Institutional Review Board of Bumin Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective and content
Key exclusion criteria (27 listed)
- 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:
- 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 or consumed more than 5 cups of caffeine per day prior to first administration of investigational drugs
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-387Also: Test1 Tablet | Drug | Reference-Test, Test- Reference |
| D484Also: Reference1 Tablet | Drug | Reference-Test, Test- Reference |
Primary outcome
AUCt of CKD-387, D484
Time frame: (Pre-dose) 0 hour, (Post-dose) 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours
Area under the CKD-387, D484 concentration in blood-time curve from 0 to last sampling time (t)
Cmax of CKD-387, D484
Time frame: (Pre-dose) 0 hour, (Post-dose) 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours
The maximum CKD-387, D484 concentration in blood sampling time (t)
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 3 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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-387 and D484 in people with Endocrine, Nutritional and Metabolic Diseases, 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 27 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 3 May 2024. 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-387, D484 (time frame: (Pre-dose) 0 hour, (Post-dose) 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 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?
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 3 May 2024.