Cardiovascular DiseasesPhase 1NCT04651881

Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fed Conditions

A Phase 1 study testing Reference drug, Test drug 1 and Test drug 2 in people with Cardiovascular Diseases, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under fed conditions Read more about this study

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Cardiovascular Diseases
What is being tested?: Reference drug, Test drug 1 and Test drug 2
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: 27 Oct 2020to 9 Dec 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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adult aged more than 19 at the time of screening
Those who had 18.0kg/m² ≤ Body Mass Index (BMI) < 30.0kg/m²
# BMI=Weight(kg) / Height(m)²
Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.
Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.
Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations.
Those who agree to double contraception method from the 1st dministration of the investigational product until 7 days after the last administration of investigational product.

Who cannot join

Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, mpacted teeth, wisdom teeth).
Those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug.
Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.
Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.
Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.
Those who have taken any drugs that may affect the clinical trial within 10 days.

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Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products.
Those who is unable to consume a high-fat meal provided during the study.
Those who are deemed insufficient to participate in this clinical study by investigators.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Central Hospital
Gyeonggi-do, Siheung-si, 15079

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fed Conditions

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under fed conditions

Read the detailed description

A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions

Conditions: Cardiovascular Diseases
Being tested: Reference drug, Test drug 1, Test drug 2
Medical subject headings: Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reference drugDrug
Also called D744
1 Cap., single oral administration under fed condition
Test drug 1Drug
Also called CKD-385 64 mg formulation I (878mg)
1 Tab., single oral administration under fed condition
Test drug 2Drug
Also called CKD-385 64 mg formulation II (878mg)
1 Tab., single oral administration under fed condition

Study groups in NCT04651881
Study group	Role	What they receive
Group 1	Experimental	1. Period 1: Reference drug 2. Period 2: Test drug 1 3. Period 3: Test drug 2 Receives: Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2
Group 2	Experimental	1. Period 1: Test drug 2 2. Period 2: Reference drug 3. Period 3: Test drug 1 Receives: Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2
Group 3	Experimental	1. Period 1: Test drug 1 2. Period 2: Test drug 2 3. Period 3: Reference drug Receives: Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2
Group 4	Experimental	1. Period 1: Test drug 2 2. Period 2: Test drug 1 3. Period 3: Reference drug Receives: Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2
Group 5	Experimental	1. Period 1: Test drug 1 2. Period 2: Reference drug 3. Period 3: Test drug 2 Receives: Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2
Group 6	Experimental	1. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1 Receives: Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2

What is being measured

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

AUCt of CKD-385
Area under the concentration-time curve from time zero to time of CKD-385
Measured: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Cmax of CKD-385
Maximum plasma concentration of CKD-385
Measured: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

Secondary outcomes (5)

AUCinf of CKD-385
Area under the concentration-time curve from zero up to infinity of CKD-385
Measured: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Tmax of CKD-385
Time to maximum plasma concentration of CKD-385
Measured: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
T1/2 of CKD-385
Terminal elimination half-life of CKD-385
Measured: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
CL/F of CKD-385
Apparent clearance of CKD-385
Measured: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Vd/F of CKD-385
Apparent Volume of Distribution of CKD-385
Measured: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

Timeline

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

27 Oct 20209 Dec 2020

First posted3 Dec 2020
Study start27 Oct 2020
Primary completion9 Dec 2020 (estimated)
Study completion9 Dec 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiovascular DiseasesStudies 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: NCT04651881
Sponsor's protocol ID: A88_09BE2016P
Status last verified: Nov 2020
First submitted: 26 Nov 2020
Last updated: 3 Dec 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fed Conditions
ClinicalTrials.gov ID: NCT04651881
Acronym / sponsor ID: A88_09BE2016P
Conditions: Cardiovascular Diseases
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 24 participants (actual)
Lead sponsor: Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 27 Oct 2020 (actual)
Primary completion: 9 Dec 2020 (estimated)
Study completion: 9 Dec 2020 (estimated)
First posted: 3 Dec 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.

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under fed conditions

Detailed description

A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions

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: Reference drug, Drug: Test drug 1, Drug: Test drug 21. Period 1: Reference drug 2. Period 2: Test drug 1 3. Period 3: Test drug 2
Group 2	Experimental	Drug: Reference drug, Drug: Test drug 1, Drug: Test drug 21. Period 1: Test drug 2 2. Period 2: Reference drug 3. Period 3: Test drug 1
Group 3	Experimental	Drug: Reference drug, Drug: Test drug 1, Drug: Test drug 21. Period 1: Test drug 1 2. Period 2: Test drug 2 3. Period 3: Reference drug
Group 4	Experimental	Drug: Reference drug, Drug: Test drug 1, Drug: Test drug 21. Period 1: Test drug 2 2. Period 2: Test drug 1 3. Period 3: Reference drug
Group 5	Experimental	Drug: Reference drug, Drug: Test drug 1, Drug: Test drug 21. Period 1: Test drug 1 2. Period 2: Reference drug 3. Period 3: Test drug 2
Group 6	Experimental	Drug: Reference drug, Drug: Test drug 1, Drug: Test drug 21. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Healthy adult aged more than 19 at the time of screening
Those who had 18.0kg/m² ≤ Body Mass Index (BMI) < 30.0kg/m²
# BMI=Weight(kg) / Height(m)²
Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.
Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.

Key exclusion criteria (9 listed)

Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, mpacted teeth, wisdom teeth).
Those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug.
Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.
Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.
Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.

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
Reference drugAlso: D7441 Cap., single oral administration under fed condition	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6
Test drug 1Also: CKD-385 64 mg formulation I (878mg)1 Tab., single oral administration under fed condition	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6
Test drug 2Also: CKD-385 64 mg formulation II (878mg)1 Tab., single oral administration under fed condition	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6

Primary outcome

AUCt of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Area under the concentration-time curve from time zero to time of CKD-385
Cmax of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Maximum plasma concentration of CKD-385

5 secondary outcomes

AUCinf of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Tmax of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
T1/2 of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
CL/F of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Vd/F of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 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.

Min-gi Kim principal investigator

CENTRAL 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 Reference drug, Test drug 1 and Test drug 2 in people with Cardiovascular Diseases, 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 7 inclusion and 9 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 3 Dec 2020. 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?

AUCt of CKD-385 (time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 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?

On the ClinicalTrials.gov record for NCT04651881.

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 3 Dec 2020.