Type II DiabetesPhase 1NCT04768673

A Study to Investigate the PK and Safety of CKD-393

A Phase 1 study testing CKD-393 formulation I, CKD-393 formulation II and D501, D759, H053 in people with Type II Diabetes, 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 investigate the pharmacokinetics and safety after oral administration of CKD-393 Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Type II Diabetes
What is being tested?: CKD-393 formulation I, CKD-393 formulation II and D501, D759, H053
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteSouth Korea
Study dates: 26 Mar 2021to 27 Apr 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 55 years
All sexes
Healthy volunteers accepted
Adult

[Inclusion Criteria]

Between 19 aged and 50 aged healthy adult
Body weight more than 55kg for male, more than 50kg for female
Body Mass Index over 18.5kg/m2 and under 27.0kg/m2
if female, the subject must satisfy more than one of the following:

subject who have reached menopause (no natural menstruation for at least 2 years.)
subject who is surgically infertile(hysterectomy or bilateral salpingo-oophorectomy, tubal ligation, or in infertile state under other method)

[Exclusion Criteria]

Subject who is currently with or have diagnosed with clinically significant hepatobiliary(severe hepatopathy, etc.), kidney(severe nephropathy, etc.), neurological, immunologic, respiratory, urinary, gastrointestinal endocrinological(diabetic ketoacidosis, diabetic coma, etc.), hematological, oncological, cardiovascular(heart failure, etc.) or metal illness
Subject with one of the following laboratory test results

AST, ALT > UNLx1.5
eGRF < 60 ml/min/1.73 m2 (MDRD formula)
immuno-serology test results in positive
Systolic blood pressure > 150mmHg or <90mmHg, Diastolic blood pressure >100mmHg or <50mmHg

Subject who has history of the following and the history may affect safety of the subject or result of this study

History of any prescription drug or herbal medicine within 14 days before first administration investigational products
History of any non-prescription drug including health food, vitamin within 7 days before first administration investigational products
History of drug-metabolizing induction/inhibition enzyme such as barbital

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Severance Hospital
Seoul, Seodaemun-gu,, 03722

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-393 and Co-administration of CKD-501, D759 and H053 Under Fed Condition in Healthy Adults

A clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393

Read the detailed description

A randomized, open-label, single-dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393 and co-administration of CKD-501, D759 and H053 under fed condition in healthy adults

Conditions: Type II Diabetes
Being tested: CKD-393 formulation I, CKD-393 formulation II, D501, D759, H053
Keywords: CKD-393, Type II Diabetes
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-393 formulation IDrug
single, oral administration of 2 tablets under fed condition
CKD-393 formulation IIDrug
single, oral administration of 2 tablets under fed condition
D501, D759, H053Drug
single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition

Study groups in NCT04768673
Study group	Role	What they receive
Group 1	Experimental	Period 1: CKD-501, D759, H053 / Period 2: CKD-393 Formulation I / Period 3: CKD-393 Formulation II Receives: Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053
Group 2	Experimental	Period 1: CKD-393 Formulation I / Period 2: CKD-393 Formulation II / Period 3: CKD-501, D759, H053 Receives: Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053
Group 3	Experimental	Period 1: CKD-393 Formulation II / Period 2: CKD-501, D759, H053 / Period 3: CKD-393 Formulation I Receives: Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053
Group 4	Experimental	Period 1: CKD-501, D759, H053 / Period 2: CKD-393 Formulation II / Period 3: CKD-393 Formulation I Receives: Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053
Group 5	Experimental	Period 1: CKD-393 Formulation I / Period 2: CKD-501, D759, H053 / Period 3: CKD-393 Formulation II Receives: Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053
Group 6	Experimental	Period 1: CKD-393 Formulation II / Period 2: CKD-393 Formulation I / Period 3: CKD-501, D759, H053 Receives: Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053

What is being measured

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

Cmax
Maximum concentration of drug in plasma
Measured: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
AUClast
Area under the plasma drug concentration-time curve to last concentration
Measured: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

Secondary outcomes (5)

AUCinf
Area under the plasma drug concentration-time curve from 0 to infinity
Measured: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Tmax
Time to maximum plasma concentration
Measured: 0 h (hours)h, 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
t1/2
Terminal elimination half-life
Measured: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Vd/F
Apparent Volume of Distribution
Measured: 0 h (hours), 0.25 h (hours)h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
CL/F
Apparent Clearance
Measured: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 202127 Apr 2021

First posted24 Feb 2021
Study start26 Mar 2021
Primary completion22 Apr 2021
Study completion27 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type II DiabetesStudies 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: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04768673
Sponsor's protocol ID: A98_04BE2022P
Status last verified: Feb 2021
First submitted: 22 Feb 2021
Last updated: 2 Aug 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type II Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2021. 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 After Oral Administration of CKD-393 and Co-administration of CKD-501, D759 and H053 Under Fed Condition in Healthy Adults
ClinicalTrials.gov ID: NCT04768673
Acronym / sponsor ID: A98_04BE2022P
Conditions: Type II Diabetes
Keywords: CKD-393, Type II Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 26 Mar 2021 (actual)
Primary completion: 22 Apr 2021 (actual)
Study completion: 27 Apr 2021 (actual)
First posted: 24 Feb 2021 (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.

A clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393

Detailed description

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-393 formulation I, Drug: CKD-393 formulation II, Drug: D501, D759, H053Period 1: CKD-501, D759, H053 / Period 2: CKD-393 Formulation I / Period 3: CKD-393 Formulation II
Group 2	Experimental	Drug: CKD-393 formulation I, Drug: CKD-393 formulation II, Drug: D501, D759, H053Period 1: CKD-393 Formulation I / Period 2: CKD-393 Formulation II / Period 3: CKD-501, D759, H053
Group 3	Experimental	Drug: CKD-393 formulation I, Drug: CKD-393 formulation II, Drug: D501, D759, H053Period 1: CKD-393 Formulation II / Period 2: CKD-501, D759, H053 / Period 3: CKD-393 Formulation I
Group 4	Experimental	Drug: CKD-393 formulation I, Drug: CKD-393 formulation II, Drug: D501, D759, H053Period 1: CKD-501, D759, H053 / Period 2: CKD-393 Formulation II / Period 3: CKD-393 Formulation I
Group 5	Experimental	Drug: CKD-393 formulation I, Drug: CKD-393 formulation II, Drug: D501, D759, H053Period 1: CKD-393 Formulation I / Period 2: CKD-501, D759, H053 / Period 3: CKD-393 Formulation II
Group 6	Experimental	Drug: CKD-393 formulation I, Drug: CKD-393 formulation II, Drug: D501, D759, H053Period 1: CKD-393 Formulation II / Period 2: CKD-393 Formulation I / Period 3: CKD-501, D759, H053

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

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-393 formulation Isingle, oral administration of 2 tablets under fed condition	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6
CKD-393 formulation IIsingle, oral administration of 2 tablets under fed condition	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6
D501, D759, H053single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6

Primary outcome

Cmax
Time frame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Maximum concentration of drug in plasma
AUClast
Time frame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Area under the plasma drug concentration-time curve to last concentration

5 secondary outcomes

AUCinf
Time frame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Tmax
Time frame: 0 h (hours)h, 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
t1/2
Time frame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Vd/F
Time frame: 0 h (hours), 0.25 h (hours)h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
CL/F
Time frame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

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 2 Aug 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.

Min Soo Park, MD, Ph.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-393 formulation I, CKD-393 formulation II and D501, D759, H053 in people with Type II Diabetes, 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?

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 2 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?

Cmax (time frame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h). 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 NCT04768673.

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 2 Aug 2021.