Diabetes Mellitus, Type 2Phase 1NCT04260438
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy Subjects
A Phase 1 study testing CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T, CKD-393 0.5/100/1000mg formulation 1 Tab. 1T and CKD-393 0.5/100/1000mg formulation 2 Tab. 1T in people with Diabetes Mellitus, Type 2, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is an open-label, randomized, fed, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-393 in healthy subjects Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T, CKD-393 0.5/100/1000mg formulation 1 Tab. 1T and CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Apr 2020to 24 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, aged between ≥ 19 and ≤ 55 years old at the time of screening.
- Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2
- BMI = Weight(kg)/ Height(m)2
- Subject who consents to use at least two clinically effective birth controls for at least 1 month following the last dose.
- Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written.
Who cannot join
- History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder.
- With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.
- Any medical history that may affect drug absorption, distribution, metabolism and excretion.
- Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse
- Thiazolidinedione
- DPP-4 inhibitor
Show all 29Show fewer
- Metformin
- Any clinically significant chronic medical illness.
- Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Individuals with one of the following laboratory test results in screening
- AST, ALT > UNL (upper normal limit) x 3
- fasting glucose < 70 mg/dL or > 125 mg/dL
- Creatinine clearance ≤ 80 mL/min
- In ECG result, QTc > 450 msec
- hCG(+) (only women)
- Individuals who had positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
- Use of any prescription drugs within 14 days prior to study drug administration.
- Use of over-the-counter medications and herbal preparations within 7 days prior to study drug administration.
- History of any clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not required medication may be allowed).
- Individuals who cannot eat standard meal provided from clinical trial center.
- Donation of blood within 60 days prior to study drug administration or apheresis within 20 days prior to the first IP administration.
- Individuals who had received a blood transfusion within 30 days prior to study drug administration.
- Exposure to any investigational drug within 6 months prior to the first IP administration.
- Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
- Individuals who had consumed grapefruit juice > 5cups/day or caffeine > 5cups/day within 30 days prior to the first IP administration or who cannot stopping consume grapefruit juice or caffeine during clinical study.
- Individuals who had drinking (alcohol > 30 g/day) within 30 days prior to the first IP administration or who cannot stopping drink.
- Heavy smoking (more than 10 cigarettes/day) within 30 days prior to screening or who cannot quit smoking during clinical study.
- Pregnant or women who may be pregnant
- Subjects having been deemed inappropriate for the trial as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Fed, Single Dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy Subjects
This study is an open-label, randomized, fed, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-393 in healthy subjects
Read the detailed description
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: 1) CKD-501 0.5mg 2) D759 3) D150 Test drug: 1) CKD-393 0.5/100/1000mg formulation Ⅰ Tab. 2) CKD-393 0.5/100/1000mg formulation Ⅱ Tab.
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T, CKD-393 0.5/100/1000mg formulation 1 Tab. 1T, CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
- 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-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1TDrug
Also called Treatment A
single oral administration under fed condition
CKD-393 0.5/100/1000mg formulation 1 Tab. 1TDrug
Also called Treatment B
single oral administration under fed condition
CKD-393 0.5/100/1000mg formulation 2 Tab. 1TDrug
Also called Treatment C
single oral administration under fed condition
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 1. Period 1: Treatment A
2. Period 2: Treatment B
3. Period 3: Treatment C Receives: Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T |
| Group 2 | Experimental | 1. Period 1: Treatment A
2. Period 2: Treatment C
3. Period 3: Treatment B Receives: Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T |
| Group 3 | Experimental | 1. Period 1: Treatment B
2. Period 2: Treatment A
3. Period 3: Treatment C Receives: Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T |
| Group 4 | Experimental | 1. Period 1: Treatment B
2. Period 2: Treatment C
3. Period 3: Treatment A Receives: Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T |
| Group 5 | Experimental | 1. Period 1: Treatment C
2. Period 2: Treatment A
3. Period 3: Treatment B Receives: Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T |
| Group 6 | Experimental | 1. Period 1: Treatment C
2. Period 2: Treatment B
3. Period 3: Treatment A Receives: Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-501, D759, D150, CKD-393
Area under the CKD-501/D759/D150/CKD-393 concentration in blood-time curve from zero to final
Measured: Time Frame: 0 hour ~ 48 hours
Cmax of CKD-501, D759, D150, CKD-393
The maximum CKD-501/D759/D150/CKD-393 concentration in blood sampling time t
Measured: Time Frame: 0 hour ~ 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start8 Apr 2020
- Primary completion15 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 24 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
- NCT04260438
- Sponsor's protocol ID
- A98_01BE1922P
- Status last verified
- Apr 2021
- First submitted
- 5 Feb 2020
- Last updated
- 30 Apr 2021
- 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 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fed, Single Dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04260438
- Acronym / sponsor ID
- A98_01BE1922P
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 7 Feb 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.
This study is an open-label, randomized, fed, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-393 in healthy subjects
Detailed description
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: 1) CKD-501 0.5mg 2) D759 3) D150 Test drug: 1) CKD-393 0.5/100/1000mg formulation Ⅰ Tab. 2) CKD-393 0.5/100/1000mg formulation Ⅱ Tab.
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
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T, Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T, Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T1. Period 1: Treatment A 2. Period 2: Treatment B 3. Period 3: Treatment C |
| Group 2 | Experimental | Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T, Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T, Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T1. Period 1: Treatment A 2. Period 2: Treatment C 3. Period 3: Treatment B |
| Group 3 | Experimental | Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T, Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T, Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T1. Period 1: Treatment B 2. Period 2: Treatment A 3. Period 3: Treatment C |
| Group 4 | Experimental | Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T, Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T, Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T1. Period 1: Treatment B 2. Period 2: Treatment C 3. Period 3: Treatment A |
| Group 5 | Experimental | Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T, Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T, Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T1. Period 1: Treatment C 2. Period 2: Treatment A 3. Period 3: Treatment B |
| Group 6 | Experimental | Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T, Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T, Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T1. Period 1: Treatment C 2. Period 2: Treatment B 3. Period 3: Treatment A |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male volunteers, aged between ≥ 19 and ≤ 55 years old at the time of screening.
- Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2
- Subject who consents to use at least two clinically effective birth controls for at least 1 month following the last dose.
- Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written.
Key exclusion criteria (29 listed)
- History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder.
- With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.
- Any medical history that may affect drug absorption, distribution, metabolism and excretion.
- Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse
- Any clinically significant chronic medical illness.
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-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1TAlso: Treatment Asingle oral administration under fed condition | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| CKD-393 0.5/100/1000mg formulation 1 Tab. 1TAlso: Treatment Bsingle oral administration under fed condition | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| CKD-393 0.5/100/1000mg formulation 2 Tab. 1TAlso: Treatment Csingle oral administration under fed condition | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
AUCt of CKD-501, D759, D150, CKD-393
Time frame: Time Frame: 0 hour ~ 48 hours
Area under the CKD-501/D759/D150/CKD-393 concentration in blood-time curve from zero to final
Cmax of CKD-501, D759, D150, CKD-393
Time frame: Time Frame: 0 hour ~ 48 hours
The maximum CKD-501/D759/D150/CKD-393 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 30 Apr 2021.
- 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-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T, CKD-393 0.5/100/1000mg formulation 1 Tab. 1T and CKD-393 0.5/100/1000mg formulation 2 Tab. 1T in people with Diabetes Mellitus, Type 2, 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 5 inclusion and 29 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 Apr 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-501, D759, D150, CKD-393 (time frame: Time Frame: 0 hour ~ 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 30 Apr 2021.