Type II Diabetes MellitusPhase 1NCT05452525

Pharmacokinetics and Safety/Tolerability Profile of CKD-379

A Phase 1 study testing CKD-379 I, CKD-379 II and D759+D745+D150 in people with Type II Diabetes Mellitus, 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 study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination Read more about this study

Who is it for?: Ages 19 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Type II Diabetes Mellitus
What is being tested?: CKD-379 I, CKD-379 II and D759+D745+D150
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: 26 Jul 2022to 21 Sep 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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Between 19 aged and 50 aged in healthy adult
50.0kg ≤ Body weight ≤ 90.0kg and 18.0kg/m2 ≤ body mass index (BMI) ≤ 27.0kg/m2

Who cannot join

Have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis ect.), hematological system, cardiovascular system(heart failure, Torsades de pointes etc.), mental illness
Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis
Have a gastrointestinal disease(Crohn's disease, ulcer ect.) history that can effect drug absorption or surgery
Those who are pregnant or breastfeeding
Those who are deemed inappropriate to participate in clinical trial by investigators

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, Jongno-gu, 03080

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single Dose, 3-period, 6-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects

A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination

Read the detailed description

A randomized, open-label, single dose, 3-period, 6-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions

Conditions: Type II Diabetes Mellitus
Being tested: CKD-379 I, CKD-379 II, D759+D745+D150
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-379 IDrug
1 tablet administration under fed condition
CKD-379 IIDrug
1 tablet administration under fed condition
D759+D745+D150Drug
3 tablet coadministration under fed condition

Study groups in NCT05452525
Study group	Role	What they receive
Sequence 1	Experimental	Period 1: Test drug(CKD-379 I) Period 2: Test drug(CKD-379 II) Period 3: Reference drug(D759+D745+D150) Receives: Drug: CKD-379 I; Drug: CKD-379 II; Drug: D759+D745+D150
Sequence 2	Experimental	Period 1: Test drug(CKD-379 I) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 II) Receives: Drug: CKD-379 I; Drug: CKD-379 II; Drug: D759+D745+D150
Sequence 3	Experimental	Period 1: Test drug(CKD-379 II) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 I) Receives: Drug: CKD-379 I; Drug: CKD-379 II; Drug: D759+D745+D150
Sequence 4	Experimental	Period 1: Test drug(CKD-379 II) Period 2: Test drug(CKD-379 I) Period 3: Reference drug(D759+D745+D150) Receives: Drug: CKD-379 I; Drug: CKD-379 II; Drug: D759+D745+D150
Sequence 5	Experimental	Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 I) Period 3: Test drug(CKD-379 II) Receives: Drug: CKD-379 I; Drug: CKD-379 II; Drug: D759+D745+D150
Sequence 6	Experimental	Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 II) Period 3: Test drug(CKD-379 I) Receives: Drug: CKD-379 I; Drug: CKD-379 II; Drug: D759+D745+D150

What is being measured

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

Cmax
Maximum plasma concentration of the drug
Measured: 0~48hours
AUClast
Area under the concentration-time curve from the time of dosing to the last measurable concentration
Measured: 0~48hours

Timeline

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

26 Jul 202221 Sep 2022

First posted11 Jul 2022
Study start26 Jul 2022
Primary completion27 Aug 2022
Study completion21 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type II 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05452525
Sponsor's protocol ID: A125_01BE2204
Status last verified: Oct 2022
First submitted: 6 Jul 2022
Last updated: 18 Oct 2022
Results posted: No
Data monitoring committee: 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 Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Single Dose, 3-period, 6-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects
ClinicalTrials.gov ID: NCT05452525
Acronym / sponsor ID: A125_01BE2204
Conditions: Type II Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 26 Jul 2022 (actual)
Primary completion: 27 Aug 2022 (actual)
Study completion: 21 Sep 2022 (actual)
First posted: 11 Jul 2022 (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 study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination

Detailed description

A randomized, open-label, single dose, 3-period, 6-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1	Experimental	Drug: CKD-379 I, Drug: CKD-379 II, Drug: D759+D745+D150Period 1: Test drug(CKD-379 I) Period 2: Test drug(CKD-379 II) Period 3: Reference drug(D759+D745+D150)
Sequence 2	Experimental	Drug: CKD-379 I, Drug: CKD-379 II, Drug: D759+D745+D150Period 1: Test drug(CKD-379 I) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 II)
Sequence 3	Experimental	Drug: CKD-379 I, Drug: CKD-379 II, Drug: D759+D745+D150Period 1: Test drug(CKD-379 II) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 I)
Sequence 4	Experimental	Drug: CKD-379 I, Drug: CKD-379 II, Drug: D759+D745+D150Period 1: Test drug(CKD-379 II) Period 2: Test drug(CKD-379 I) Period 3: Reference drug(D759+D745+D150)
Sequence 5	Experimental	Drug: CKD-379 I, Drug: CKD-379 II, Drug: D759+D745+D150Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 I) Period 3: Test drug(CKD-379 II)
Sequence 6	Experimental	Drug: CKD-379 I, Drug: CKD-379 II, Drug: D759+D745+D150Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 II) Period 3: Test drug(CKD-379 I)

Who may qualify

Ages: 19 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Between 19 aged and 50 aged in healthy adult
50.0kg ≤ Body weight ≤ 90.0kg and 18.0kg/m2 ≤ body mass index (BMI) ≤ 27.0kg/m2

Key exclusion criteria (5 listed)

Have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis ect.), hematological system, cardiovascular system(heart failure, Torsades de pointes etc.), mental illness
Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis
Have a gastrointestinal disease(Crohn's disease, ulcer ect.) history that can effect drug absorption or surgery
Those who are pregnant or breastfeeding
Those who are deemed inappropriate to participate in clinical trial by investigators

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-379 I1 tablet administration under fed condition	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
CKD-379 II1 tablet administration under fed condition	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
D759+D745+D1503 tablet coadministration under fed condition	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6

Primary outcome

Cmax
Time frame: 0~48hours
Maximum plasma concentration of the drug
AUClast
Time frame: 0~48hours
Area under the concentration-time curve from the time of dosing to the last measurable concentration

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 18 Oct 2022.
Individual participant dataSharing planned: No

Related trials for Type II Diabetes Mellitus

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cfMSC Therapy for Diabetes
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RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Active, not recruiting
The GRoceries Aimed at Increasing Nutrition Study
Type 2 Diabetes, Type II Diabetes Mellitus
RecruitingPhase 2
A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
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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.

Jaeseong Oh, M.D., Ph.D. principal investigator

Seoul National University 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-379 I, CKD-379 II and D759+D745+D150 in people with Type II 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 2 inclusion and 5 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 18 Oct 2022. 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: 0~48hours). 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 NCT05452525.

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 18 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.