HypertensionPhase 1NCT04019743

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers

A Phase 1 study testing CKD-330 16/10mg Tab. 1T and D086 Tab. 1T, CKD-333 16/10/40mg formulation 1 Tab. 1T and CKD-333 16/10/40mg formulation 2 Tab. 1T in people with Hypertension and Dyslipidemias, 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

This study is a randomized, open-label, fasted, single dose, crossover study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers. Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension, Dyslipidemias
What is being tested?: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T, CKD-333 16/10/40mg formulation 1 Tab. 1T and CKD-333 16/10/40mg 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: 28 Jul 2019to 4 Sep 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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

19 to 55 years old healthy subject at the screening
Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and a total body weight ≥ 55 kg
BMI = Weight(kg)/ Height(m)2
Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG etc.)
Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational drug
Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
Individuals with the ability and willingness to participate during the study period

Who cannot join

Individuals with a medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease (excluding simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
Individuals with a medical history of gastrointestinal disease (e.g., gullet disease including esophageal achalasia, esophagostenosis, or Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction surgery) that may affect drug absorption
Individuals with the following laboratory test results:
ALT or AST > 2x the upper limit of the normal range
CK > 3x the upper limit of the normal range
A history of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)

Show all 30Show fewer

Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening
Individuals who had been administered investigational product(s) of other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
Individuals with the following vital signs results at screening Individuals who had sitting blood pressure ≥90 mmHg or <140 mmHg (systolic) or ≥90 mmHg or <60 mmHg (diastolic)
Individuals with a medical history of significant alcohol abuse or drug abuse within one year prior to the screening
Individuals who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first dose of investigational product(s)
Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)
Individuals with severe acute/chronic medical or psychiatric conditions that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results
Individuals with hypersensitivity to ingredients used in the investigational product(s)
Patient with hyperkalemia
Patients with hepatopathy
Patients with hereditary angioedema, ACE inhibitors or angiotensin Ⅱ receptor antagonists who have a history of angioedema
Primary hyperaldosteronism
Patients with aortic valve stenosis, mitral (valve) stenosis, hypertrophic obstructive cardiomyopathy
Patients with ischemic heart disease, ischemic cardiovascular disease, cerebrovascular disease
Patients with Intravascular volume depletion
Patients with nephropathy (eGFR<60 ml/min/1.73 m2)
Patients with renal artery stenosis
Patients with muscle disease
Patients with Hypothyroidism
Women who are pregnant or may be pregnant
Patients with a history of muscle toxicity when using statins or fibrates
Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
Individuals who were deemed to be inappropriate to participate in the study by the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chonbuk National University Hospital
Jeonju, South Korea

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers

This study is a randomized, open-label, fasted, single dose, crossover study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.

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 14 days.

Reference drug: 1) CKD-330 16/10mg Tab. 2) D086 Tab. Test drug: 1) CKD-333 16/10/40mg formulation 1 Tab. 2) CKD-333 16/10/40mg formulation 2 Tab.

Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Conditions: Hypertension, Dyslipidemias
Being tested: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T, CKD-333 16/10/40mg formulation 1 Tab. 1T, CKD-333 16/10/40mg formulation 2 Tab. 1T
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-330 16/10mg Tab. 1T and D086 Tab. 1TDrug
Also called Treatment A
single oral administration under fasting condition
CKD-333 16/10/40mg formulation 1 Tab. 1TDrug
Also called Treatment B
single oral administration under fasting condition
CKD-333 16/10/40mg formulation 2 Tab. 1TDrug
Also called Treatment C
single oral administration under fasting condition

Study groups in NCT04019743
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-330 16/10mg Tab. 1T and D086 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
Group 2	Experimental	1. Period 1: Treatment C 2. Period 2: Treatment A 3. Period 3: Treatment B Receives: Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
Group 3	Experimental	1. Period 1: Treatment B 2. Period 2: Treatment C 3. Period 3: Treatment A Receives: Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
Group 4	Experimental	1. Period 1: Treatment C 2. Period 2: Treatment B 3. Period 3: Treatment A Receives: Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
Group 5	Experimental	1. Period 1: Treatment B 2. Period 2: Treatment A 3. Period 3: Treatment C Receives: Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
Group 6	Experimental	1. Period 1: Treatment A 2. Period 2: Treatment C 3. Period 3: Treatment B Receives: Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T

What is being measured

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

AUCt of CKD-330, D086, CKD-333
Area under the CKD-330/D086/CKD-333 concentration in blood-time curve from zero to final
Measured: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Cmax of CKD-330, D086, CKD-333
The maximum CKD-330/D086/CKD-333 concentration in blood sampling time t
Measured: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

Timeline

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

28 Jul 20194 Sep 2019

First posted15 Jul 2019
Study start28 Jul 2019
Primary completion30 Aug 2019
Study completion4 Sep 2019

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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04019743
Sponsor's protocol ID: A70_07BE1906P
Status last verified: Jan 2020
First submitted: 11 Jul 2019
Last updated: 30 Jan 2020
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?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers
ClinicalTrials.gov ID: NCT04019743
Acronym / sponsor ID: A70_07BE1906P
Conditions: Hypertension, Dyslipidemias
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 28 Jul 2019 (actual)
Primary completion: 30 Aug 2019 (actual)
Study completion: 4 Sep 2019 (actual)
First posted: 15 Jul 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.

This study is a randomized, open-label, fasted, single dose, crossover study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.

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 14 days.

Reference drug: 1) CKD-330 16/10mg Tab. 2) D086 Tab. Test drug: 1) CKD-333 16/10/40mg formulation 1 Tab. 2) CKD-333 16/10/40mg formulation 2 Tab.

Pharmacokinetic blood samples are collected up to 72hrs. 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-330 16/10mg Tab. 1T and D086 Tab. 1T, Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T, Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T1. Period 1: Treatment A 2. Period 2: Treatment B 3. Period 3: Treatment C
Group 2	Experimental	Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T, Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T, Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T1. Period 1: Treatment C 2. Period 2: Treatment A 3. Period 3: Treatment B
Group 3	Experimental	Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T, Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T, Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T1. Period 1: Treatment B 2. Period 2: Treatment C 3. Period 3: Treatment A
Group 4	Experimental	Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T, Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T, Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T1. Period 1: Treatment C 2. Period 2: Treatment B 3. Period 3: Treatment A
Group 5	Experimental	Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T, Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T, Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T1. Period 1: Treatment B 2. Period 2: Treatment A 3. Period 3: Treatment C
Group 6	Experimental	Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T, Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T, Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T1. Period 1: Treatment A 2. Period 2: Treatment C 3. Period 3: Treatment B

Who may qualify

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

Key inclusion criteria (8 listed)

19 to 55 years old healthy subject at the screening
Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and a total body weight ≥ 55 kg
Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG etc.)
Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational drug

Key exclusion criteria (30 listed)

Individuals with a medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease (excluding simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
Individuals with a medical history of gastrointestinal disease (e.g., gullet disease including esophageal achalasia, esophagostenosis, or Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction surgery) that may affect drug absorption
Individuals with the following laboratory test results:
A history of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening

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-330 16/10mg Tab. 1T and D086 Tab. 1TAlso: Treatment Asingle oral administration under fasting condition	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6
CKD-333 16/10/40mg formulation 1 Tab. 1TAlso: Treatment Bsingle oral administration under fasting condition	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6
CKD-333 16/10/40mg formulation 2 Tab. 1TAlso: Treatment Csingle oral administration under fasting condition	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6

Primary outcome

AUCt of CKD-330, D086, CKD-333
Time frame: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Area under the CKD-330/D086/CKD-333 concentration in blood-time curve from zero to final
Cmax of CKD-330, D086, CKD-333
Time frame: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
The maximum CKD-330/D086/CKD-333 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 Jan 2020.
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?

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 8 inclusion and 30 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 Jan 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?

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-330, D086, CKD-333 (time frame: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 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 NCT04019743.

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 Jan 2020.