HypertensionPhase 1NCT03920579

A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers

A Phase 1 study testing CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337 and D013 in people with Hypertension and Dyslipidemias, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers Read more about this study

Who is it for?: Ages 19 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hypertension, Dyslipidemias
What is being tested?: CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337 and D013
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSouth Korea
Study dates: 1 Apr 2019to May 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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers aged between ≥20 and ≤45 years old
Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2
Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests
Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Who cannot join

History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug
Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests

Trial locations and contacts

1 site in 1 country.

Dongseong Shin, M.D, Ph.D contact

+82-32-460-9459

dsshin@gilhospital.com

South Korea1 site, 1 recruiting

Gachon University Gil Medical Center
Incheon, 21565
Dongseong Shin, M.D, Ph.D, +82-32-460-9459, dsshin@gilhospital.com
Recruiting

Other trials in South Korea

About this study

Official title: A Sequence-randomized, Open-label, 3-way Crossover, Single Oral Dose Clinical Trial to Investigate the Pharmacokinetic Characteristics and Safety/Tolerability According to Formulations of CKD-386 in Healthy Male Volunteers

a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

Read the detailed description

A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

Conditions: Hypertension, Dyslipidemias
Being tested: CKD-386 formulation 1, CKD-386 formulation 2, D326, D337 and D013
Keywords: CKD-386, Pharmacokinetics, D326, D337, D013
Medical subject headings: Hypertension, Dyslipidemias

What participants receive

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

CKD-386 formulation 1Drug
Also called CKD-386 Test 1
A single oral dose of 1 tablet under fasting conditions for each period
CKD-386 formulation 2Drug
Also called CKD-386 Test 2
A single oral dose of 1 tablet under fasting conditions for each period
D326, D337 and D013Drug
Also called CKD-386 Reference
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period

Study groups in NCT03920579
Study group	Role	What they receive
Sequence 1	Experimental	Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once) Receives: Drug: CKD-386 formulation 1; Drug: CKD-386 formulation 2; Drug: D326, D337 and D013
Sequence 2	Experimental	Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once) Receives: Drug: CKD-386 formulation 1; Drug: CKD-386 formulation 2; Drug: D326, D337 and D013
Sequence 3	Experimental	Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once) Receives: Drug: CKD-386 formulation 1; Drug: CKD-386 formulation 2; Drug: D326, D337 and D013
Sequence 4	Experimental	Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013 Receives: Drug: CKD-386 formulation 1; Drug: CKD-386 formulation 2; Drug: D326, D337 and D013
Sequence 5	Experimental	Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once) Receives: Drug: CKD-386 formulation 1; Drug: CKD-386 formulation 2; Drug: D326, D337 and D013
Sequence 6	Experimental	Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once) Receives: Drug: CKD-386 formulation 1; Drug: CKD-386 formulation 2; Drug: D326, D337 and D013

What is being measured

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

AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
AUC0-t: Area under the concentration-time curve from time zero to time
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
Cmax: Maximum plasma concentration of the drug
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

Secondary outcomes (7)

AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
AUCinf: Area under the concentration-time curve from zero up to ∞
Measured: 0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31
Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Tmax: Time to maximum plasma concentration
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
t1/2: Terminal elimination half-life
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
CL/F: Apparent total body clearance of the drug
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Vd/F: Apparent volume of distribution
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
AUC0-t: Area under the concentration-time curve from time zero to time
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Cmax: Maximum plasma concentration of the drug
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

Timeline

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

1 Apr 2019May 2019

First posted19 Apr 2019
Study start1 Apr 2019
Primary completionMay 2019 (estimated)
Study completionMay 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies 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: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03920579
Sponsor's protocol ID: 183PK18034
Status last verified: Apr 2019
First submitted: 8 Apr 2019
Last updated: 19 Apr 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Dongseong Shin, M.D, Ph.D

+82-32-460-9459

dsshin@gilhospital.com

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 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Sequence-randomized, Open-label, 3-way Crossover, Single Oral Dose Clinical Trial to Investigate the Pharmacokinetic Characteristics and Safety/Tolerability According to Formulations of CKD-386 in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT03920579
Acronym / sponsor ID: 183PK18034
Conditions: Hypertension, Dyslipidemias
Keywords: CKD-386, Pharmacokinetics, D326, D337, D013
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 1 Apr 2019 (actual)
Primary completion: May 2019 (estimated)
Study completion: May 2019 (estimated)
First posted: 19 Apr 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.

a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

Detailed description

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-386 formulation 1, Drug: CKD-386 formulation 2, Drug: D326, D337 and D013Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once)
Sequence 2	Experimental	Drug: CKD-386 formulation 1, Drug: CKD-386 formulation 2, Drug: D326, D337 and D013Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once)
Sequence 3	Experimental	Drug: CKD-386 formulation 1, Drug: CKD-386 formulation 2, Drug: D326, D337 and D013Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once)
Sequence 4	Experimental	Drug: CKD-386 formulation 1, Drug: CKD-386 formulation 2, Drug: D326, D337 and D013Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013
Sequence 5	Experimental	Drug: CKD-386 formulation 1, Drug: CKD-386 formulation 2, Drug: D326, D337 and D013Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once)
Sequence 6	Experimental	Drug: CKD-386 formulation 1, Drug: CKD-386 formulation 2, Drug: D326, D337 and D013Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once)

Who may qualify

Ages: 19 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy volunteers aged between ≥20 and ≤45 years old
Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2
Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests
Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Key exclusion criteria (3 listed)

History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug
Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests

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-386 formulation 1Also: CKD-386 Test 1A single oral dose of 1 tablet under fasting conditions for each period	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
CKD-386 formulation 2Also: CKD-386 Test 2A single oral dose of 1 tablet under fasting conditions for each period	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
D326, D337 and D013Also: CKD-386 ReferenceA single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6

Primary outcome

AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
AUC0-t: Area under the concentration-time curve from time zero to time
Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax: Maximum plasma concentration of the drug

7 secondary outcomes

AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31
Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
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.

Dongseong Shin, M.D, Ph.D contact

+82-32-460-9459

dsshin@gilhospital.com

Dongseong Shin, M.D, Ph.D principal investigator

Clinical Trials Center, Gil Medical Center, Incheon, Korea

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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 19 Apr 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?

Contact Dongseong Shin, M.D, Ph.D (+82-32-460-9459, dsshin@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013 (time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31). 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 NCT03920579.

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 19 Apr 2019.