Type2 Diabetes MellitusPhase 1NCT04223895
A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Adult Volunteers
A Phase 1 study testing CKD-386 Formulation 1, CKD-386 Formulation 2 and D012, D326 and D337 in people with Type2 Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics and Safety/Tolerability of CKD-386 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- CKD-386 Formulation 1, CKD-386 Formulation 2 and D012, D326 and D337
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 15 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who are over 19 years old at the screening visit
- Those who weigh more than 50kg (45kg or more for women) at the screening visit and have a body mass index (BMI) within the range of 18-30kg/m^2
- Those who meet the following conditions of blood pressure measured in a sitting position after sufficient rest at the screening visit
- Systolic blood pressure: 90mmHg or more and 139mmHg or less
- Diastolic blood pressure: 60mmHg or more and 89mmHg or less
- Those who no congenital or chronic disease based on screening and no pathological symptoms or findings in medical examination results (e.g. EEG, ECG, chest and gastroscopy or gastrointestinal radiographs, if necessary)
- The person in charge of the examination (or authorized test physician) who has determined that the test subject is suitable for the diagnostic test and electrocardiogram test such as hematology test, blood chemistry test, serology test and urine test performed according to the characteristics of the investigational drug product
- Persons agreeing to exclude the possibility of pregnancy using appropriate contraceptive methods and not providing sperm or eggs from the date of first administration of the investigational drug to the 14th day after the last administration of the investigational drug
Who cannot join
- Those who participated in other clinical trials (including bioequivalence studies) within 6 months before the first dose and received the investigational drug
- Those who used drugs that induce and inhibit metabolic enzymes, such as barbital drugs, within one month before the first dose, or who used drugs that may interfere with this test within 10 days before the first dose
- Those who have donated whole blood within 2 months before the first dose or component donation within 1 month, or have transfused within 1 month
- Those who have had a history of gastrointestinal resection that may affect the absorption of the investigational drug (except appendectomy and hernia surgery)
- A person who meets the following conditions within one month before the first administration date
- Excess alcohol: 21 cups / week for men and 14 cups / week for women.
Show all 22Show fewer
- [1 glass = 50 mL of shochu or 30 mL of liquor or 250 mL of beer]
- Smokers exceeding 20 cigarettes per day
- Patients with the following diseases
- Patients with hypersensitivity to the main constituents or components of the investigational drug
- Severe hepatic impairment, biliary atresia or cholestasis
- Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists
- Diabetes mellitus
- Patients with moderate to severe renal impairment [glomerular filtration rate (eGFR) <60 mL / min / 1.73m^2]
- Renal vascular hypertension patients
- Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit
- Patients with myopathy or have a history of family or genetic history of myopathy
- Hypothyroidism
- If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs
- Genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
- person who is considered to be unsuitable for participation in this clinical trial for reasons other than the above selection / exclusion criteria.
- In the case of female volunteers, the suspected or lactating woman
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-386 With Co-administration of D012, D326, and D337 in Healthy Adult Volunteers
The purpose of this study is to evaluate the pharmacokinetics and Safety/Tolerability of CKD-386
Read the detailed description
Phase I clinical trial to compare the pharmacokinetics and tolerability of CKD-386 with co-administration of D012, D326, and D337 in healthy adult volunteers
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- CKD-386 Formulation 1, CKD-386 Formulation 2, D012, D326 and D337
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-386 Formulation 1Drug
Also called CKD-386 F1
A single oral dose of 1 tablet under fasting conditions for each period
CKD-386 Formulation 2Drug
Also called CKD-386 F2
A single oral dose of 1 tablet under fasting conditions for each period
D012, D326 and D337Drug
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Period 1: D012, D326, D337(3 tabs, once) / Period 2: CKD-386 F1(1 tab, once)/ Period 3: CKD-386 F2(1 tab, once) Receives: Drug: CKD-386 Formulation 1; Drug: CKD-386 Formulation 2; Drug: D012, D326 and D337 |
| Group 2 | Experimental | Period 1: D012, D326, D337(3 tabs, once) / Period 2: CKD-386 F2(1 tab, once)/ Period 3: CKD-386 F1(1 tab, once) Receives: Drug: CKD-386 Formulation 1; Drug: CKD-386 Formulation 2; Drug: D012, D326 and D337 |
| Group 3 | Experimental | Period 1: CKD-386 F1(1 tab, once) / Period 2: D012, D326, D337(3 tabs, once) Period 3: CKD-386 F2(1 tab, once) Receives: Drug: CKD-386 Formulation 1; Drug: CKD-386 Formulation 2; Drug: D012, D326 and D337 |
| Group 4 | Experimental | Period 1: CKD-386 F1(1 tab, once) / Period 2: CKD-386 F2(1 tab, once) / Period 3: D012, D326, D337(3 tabs, once) Receives: Drug: CKD-386 Formulation 1; Drug: CKD-386 Formulation 2; Drug: D012, D326 and D337 |
| Group 5 | Experimental | Period 1: CKD-386 F2(1 tab, once) / Period 2: D012, D326, D337(3 tabs, once)/ Period 3: CKD-386 F1(1 tab, once) Receives: Drug: CKD-386 Formulation 1; Drug: CKD-386 Formulation 2; Drug: D012, D326 and D337 |
| Group 6 | Experimental | Period 1: CKD-386 F2(1 tab, once) / Period 2: CKD-386 F1(1 tab, once) / Period 3: D012, D326, D337(3 tabs, once) Receives: Drug: CKD-386 Formulation 1; Drug: CKD-386 Formulation 2; Drug: D012, D326 and D337 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
AUCt: Area under the concentration-time curve
Measured: 0(predose)~72 hours
Cmax of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Cmax: Maximum plasma concentration of the drug
Measured: 0(predose)~72 hours
Secondary outcomes (6)
AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
AUCinf: Area under the concentration-time curve from zero up to ∞
Measured: 0(predose)~72 hours
tmax each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
tmax: Time to maximum plasma concentration
Measured: 0(predose)~72 hours
AUCt/AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
AUCt/AUCinf: AUCt/AUCinf Ratio
Measured: 0(predose)~72 hours
t1/2 each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
t1/2: Terminal elimination half-life
Measured: 0(predose)~72 hours
AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D326, D337
AUCt: Area under the concentration-time curve
Measured: 0(predose)~72 hours
Cmax of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D326, D337
Cmax: Maximum plasma concentration of the drug
Measured: 0(predose)~72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion4 Mar 2020 (estimated)
- Study completion15 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 70-4665-9174 70-4665-9174, Principal investigator, H Plus Yangji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223895
- Sponsor's protocol ID
- A83_04BE1917P
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 10 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-386 With Co-administration of D012, D326, and D337 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04223895
- Acronym / sponsor ID
- A83_04BE1917P
- Conditions
- Type2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 4 Mar 2020 (estimated)
- Study completion
- 15 Jun 2020 (estimated)
- First posted
- 10 Jan 2020 (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.
The purpose of this study is to evaluate the pharmacokinetics and Safety/Tolerability of CKD-386
Detailed description
Phase I clinical trial to compare the pharmacokinetics and tolerability of CKD-386 with co-administration of D012, D326, and D337 in healthy adult volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: CKD-386 Formulation 1, Drug: CKD-386 Formulation 2, Drug: D012, D326 and D337Period 1: D012, D326, D337(3 tabs, once) / Period 2: CKD-386 F1(1 tab, once)/ Period 3: CKD-386 F2(1 tab, once) |
| Group 2 | Experimental | Drug: CKD-386 Formulation 1, Drug: CKD-386 Formulation 2, Drug: D012, D326 and D337Period 1: D012, D326, D337(3 tabs, once) / Period 2: CKD-386 F2(1 tab, once)/ Period 3: CKD-386 F1(1 tab, once) |
| Group 3 | Experimental | Drug: CKD-386 Formulation 1, Drug: CKD-386 Formulation 2, Drug: D012, D326 and D337Period 1: CKD-386 F1(1 tab, once) / Period 2: D012, D326, D337(3 tabs, once) Period 3: CKD-386 F2(1 tab, once) |
| Group 4 | Experimental | Drug: CKD-386 Formulation 1, Drug: CKD-386 Formulation 2, Drug: D012, D326 and D337Period 1: CKD-386 F1(1 tab, once) / Period 2: CKD-386 F2(1 tab, once) / Period 3: D012, D326, D337(3 tabs, once) |
| Group 5 | Experimental | Drug: CKD-386 Formulation 1, Drug: CKD-386 Formulation 2, Drug: D012, D326 and D337Period 1: CKD-386 F2(1 tab, once) / Period 2: D012, D326, D337(3 tabs, once)/ Period 3: CKD-386 F1(1 tab, once) |
| Group 6 | Experimental | Drug: CKD-386 Formulation 1, Drug: CKD-386 Formulation 2, Drug: D012, D326 and D337Period 1: CKD-386 F2(1 tab, once) / Period 2: CKD-386 F1(1 tab, once) / Period 3: D012, D326, D337(3 tabs, once) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Those who are over 19 years old at the screening visit
- Those who weigh more than 50kg (45kg or more for women) at the screening visit and have a body mass index (BMI) within the range of 18-30kg/m^2
- Those who meet the following conditions of blood pressure measured in a sitting position after sufficient rest at the screening visit
- Those who no congenital or chronic disease based on screening and no pathological symptoms or findings in medical examination results (e.g. EEG, ECG, chest and gastroscopy or gastrointestinal radiographs, if necessary)
- The person in charge of the examination (or authorized test physician) who has determined that the test subject is suitable for the diagnostic test and electrocardiogram test such as hematology test, blood chemistry test, serology test and urine test performed according to the characteristics of the investigational drug product
Key exclusion criteria (22 listed)
- Those who participated in other clinical trials (including bioequivalence studies) within 6 months before the first dose and received the investigational drug
- Those who used drugs that induce and inhibit metabolic enzymes, such as barbital drugs, within one month before the first dose, or who used drugs that may interfere with this test within 10 days before the first dose
- Those who have donated whole blood within 2 months before the first dose or component donation within 1 month, or have transfused within 1 month
- Those who have had a history of gastrointestinal resection that may affect the absorption of the investigational drug (except appendectomy and hernia surgery)
- A person who meets the following conditions within one month before the first administration date
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-386 Formulation 1Also: CKD-386 F1A single oral dose of 1 tablet under fasting conditions for each period | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| CKD-386 Formulation 2Also: CKD-386 F2A single oral dose of 1 tablet under fasting conditions for each period | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| D012, D326 and D337A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Time frame: 0(predose)~72 hours
AUCt: Area under the concentration-time curve
Cmax of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Time frame: 0(predose)~72 hours
Cmax: Maximum plasma concentration of the drug
6 secondary outcomes
AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Time frame: 0(predose)~72 hours
tmax each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Time frame: 0(predose)~72 hours
AUCt/AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Time frame: 0(predose)~72 hours
t1/2 each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Time frame: 0(predose)~72 hours
AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D326, D337
Time frame: 0(predose)~72 hours
Cmax of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D326, D337
Time frame: 0(predose)~72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
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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.
70-4665-9174 70-4665-9174 principal investigator
H Plus Yangji Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-386 Formulation 1, CKD-386 Formulation 2 and D012, D326 and D337 in people with Type2 Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical.
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 22 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 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Yook-Hwan Noh (82-70-4665-9174, yook.noh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337 (time frame: 0(predose)~72 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 10 Jan 2020.