Type 2 Diabetes MellitusPhase 1NCT03849339
Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 Under Fed Condition
A Phase 1 study testing CKD-387 and D635 in people with Type 2 Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 under fed condition in healthy adults. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- CKD-387 and D635
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jan 2019to 28 Feb 2019
- 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 aged 19 to 55 years
- Females must be menopause or surgical infertility
- Signed informed consent form
- Other inclusion criteria, as defined in the protocol
Who cannot join
- History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
- Clinical laboratory test values are outside the accepted normal range at Screening
- aspartate aminotransferase(AST), alanine aminotransferase(ALT) > 1.25 times the upper limit of the normal range
- Total Bilirubin > 1.5 times the upper limit of the normal range
- creatine phosphokinase(CPK) > 1.5 times the upper limit of the normal range
- estimated Glomerular Filtration Rate(eGFR, MDRD* formula) < 60 mL/min/1.73m2 (*MDRD: Modification of Diet in Renal Disease)
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- Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis
- systolic blood pressure(SBP) ≥ 150 mmHg or < 90 mmHg, diastolic blood pressure(DBP) > 100 mmHg or < 50 mmHg
- Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization
- Participated in a clinical trial within 90 days prior to 1st IP dosing
- Not eligible to participate for the study at the discretion of Investigator
- Other exclusive inclusion criteria, as defined in the protocol
Trial locations and contacts
1 site in 1 country.
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 CKD-387 and D635 Under Fed Condition in Healthy Adults
The purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 under fed condition in healthy adults.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- CKD-387, D635
- 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-387Drug
Test drug
D635Drug
Reference drug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | * Period 1: D635
* Period 2: CKD-387 Receives: Drug: CKD-387; Drug: D635 |
| Group 2 | Experimental | * Period 1: CKD-387
* Period 2: D635 Receives: Drug: CKD-387; Drug: D635 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Metformin
Maximum plasma concentration of Metformin
Measured: 0 hour ~ 48 hour after drug administration
AUClast of Metformin
Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration
Measured: 0 hour ~ 48 hour after drug administration
Secondary outcomes (5)
AUCinf of Metformin
Area under the plasma concentration of Metformin-time curve from time zero to infinity
Measured: 0 hour ~ 48 hour after drug administration
Tmax of Metformin
Time to reach maximum (peak) plasma concentration of Metformin following drug administration
Measured: 0 hour ~ 48 hour after drug administration
t1/2 of Metformin
Half-life of Metformin
Measured: 0 hour ~ 48 hour after drug administration
CL/F of Metformin
Apparent clearance of Metformin
Measured: 0 hour ~ 48 hour after drug administration
Vd/F of Metformin
Apparent volume of distribution of Metformin
Measured: 0 hour ~ 48 hour after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start28 Jan 2019
- Primary completion21 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Soo Park, Ph.D. M.D., Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849339
- Sponsor's protocol ID
- 184BE18028
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 Under Fed Condition in Healthy Adults
- ClinicalTrials.gov ID
- NCT03849339
- Acronym / sponsor ID
- 184BE18028
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 21 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 21 Feb 2019 (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 the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 under fed condition in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: CKD-387, Drug: D635* Period 1: D635 * Period 2: CKD-387 |
| Group 2 | Experimental | Drug: CKD-387, Drug: D635* Period 1: CKD-387 * Period 2: D635 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults aged 19 to 55 years
- Females must be menopause or surgical infertility
- Signed informed consent form
- Other inclusion criteria, as defined in the protocol
Key exclusion criteria (12 listed)
- History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
- Clinical laboratory test values are outside the accepted normal range at Screening
- Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization
- Participated in a clinical trial within 90 days prior to 1st IP dosing
- Not eligible to participate for the study at the discretion of Investigator
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-387Test drug | Drug | Group 1, Group 2 |
| D635Reference drug | Drug | Group 1, Group 2 |
Primary outcome
Cmax of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
Maximum plasma concentration of Metformin
AUClast of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration
5 secondary outcomes
AUCinf of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
Tmax of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
t1/2 of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
CL/F of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
Vd/F of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
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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.
Min Soo Park, Ph.D. M.D. principal investigator
Severance Hospital
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 D635 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 4 inclusion and 12 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 21 Feb 2019. 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?
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?
Cmax of Metformin (time frame: 0 hour ~ 48 hour after drug administration). 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 21 Feb 2019.