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HypertensionPhase 1CKD-341NCT05921435

Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic After Oral Administration of CKD-341 and D958 in Healthy Adults

A Phase 1 study testing CKD-341, D958 in people with Hypertension, 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 compare and evaluate the safety and pharmacokinetics of CKD-341 Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
CKD-341, D958
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteSouth Korea
Study dates
20 Jun 2023to 15 Sep 2023
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 subjects aged over 19 years (inclusive) at the time of screening.
  • Subjects weighing at least 50.0 kg with a Body Mass Index(BMI) between 18.0 kg/m2 and 30.0 kg/m2 (inclusive) at the time of screening.
  • BMI(kg/m2) = weight (kg) / {height (m)}2
  • Subjects with neither congenital nor chronic diseases requiring treatment, and no abnormal symptoms or findings upon medical examination.
  • Subjects considered eligible for the study participation in accordance with the results of vital signs, physical examination, 12-lead ECG, and clinical laboratory tests at the time of screening.
  • Subjects who have a full understanding in participation of the study, voluntarily provide a written consent in participation, and give full agreement in following the subject guidelines throughout the entire study period.

Who cannot join

  • Subjects with any clinically significant past and present hepatic, renal, nervous, respiratory, endocrine, circulatory, oncologic, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases, psychosis disorders, or a medical history of at least one of the following conditions (past and present):
  • 1-1) Liver disorders and biliary obstructive disease 1-2) Kidney disorders 1-3) Shock 1-4) Hypokalemia, hyponatremia, hypercalcemia 1-5) Addison's syndrome 1-6) Primary aldosteronism 1-7) Aortic stenosis, mitral obstruction or hypertrophic obstructive cardiomyopathy 1-8) Renovascular hypertension or anuria 1-9) Hypotension 1-10) Vascular sclerosis or cerebral arteriosclerosis 1-11) Hyperuricemia (with gout or uric acid stone) or diabetes (including family history) 1-12) Hyperparathyroidism 1-13) Sympathectomy
  • For women, pregnant (urine-HCG positive) or lactating women
  • History of any clinically significant hypersensitivity reactions or hypersensitivity reactions to any of the IP main ingredients, formulation additives, and other drugs (including dihydropyridine derivatives, thiazide diuretics, or sulfonamide drugs).
  • Subjects on lithium therapy or salt-restricted therapy
  • Subjects with hereditary issues of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
Show all 29Show fewer
  • Subjects with a past medical history of gastrointestinal disease (Crohn's disease, ulcers, acute/chronic pancreatitis, etc.) or gastrointestinal surgeries (except for simple appendectomy and hernia repair) which may affect the absorption of the IP.
  • Subjects with clinically significant 12-lead ECG findings including the following results at the time of screening:
  • QTc > 450 ms for men, QTc > 470 ms for women
  • PR interval > 200 ms
  • QRS duration > 120 ms
  • Subjects with laboratory test results as follows at the time of screening:
  • Liver function test (AST, ALT, ALP, γ-GTP and total bilirubin) values exceeding twice the upper normal limit
  • Creatinine values outside the reference ranges or eGFR < 60 mL/min/1.73m2 (eGFR is estimated using the Chronic Kidney Disease Epidemiology Collaboration formula)
  • CPK > 2.5 times the upper limit of normal range on clinical laboratory tests
  • Subjects with a past history of drug abuse or a positive urine drug screening test
  • Subjects with systolic blood pressure ≥ 150 mmHg or ≤ 90 mmHg; diastolic blood pressure ≥ 100 mmHg or ≤ 60 mmHg; pulse rate ≤ 40 beats/min or ≥ 100 beats/min, when measured in a seated position without an abrupt change in body position for at least 3 minutes at the time of screening
  • Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals, within 1 month prior to the first IP administration
  • Subjects following an unusual diet or consumption of food which may affect the absorption, distribution, metabolism and excretion of the IP
  • Subjects who have taken any prescribed medications including cyclosporine, nonsteroidal anti-inflammatory drugs, terfenadine, astemizole, digitalis, glucocorticoids, adrenocorticotropic hormone, and agents that affect the renin-angiotensin-aldosterone system (RAAS) or herbal medicine within 2 weeks or any over-the-counter drug or vitamin supplements within 10 days prior to the first IP administration (except for circumstances considered acceptable with no concerned effect on the pharmacokinetics (PK) of the IP at the investigator's discretion)
  • Subjects who have participated and were given any other study drugs in other clinical study within 6 months prior to the first IP administration (the last day of IP administration is considered the end-of-study)
  • Subjects who have donated whole blood within 2 months or blood components within 1 month or received a blood transfusion within 1 month prior to the first IP administration or subjects unable to abstain from donating blood from the time of consent until PSV
  • Subjects who have consistently drunk alcohol within 6 months exceeding 21 units/week (1 unit = 10 g = 12.5 mL of pure alcohol) prior to the first IP administration or are unable to refrain from drinking from the time of consent until PSV
  • Subjects who have smoked more than 10 cigarettes/day on average 3 months prior to the first IP administration and are unable to oblige the no-smoking rules from 24 hours prior to IP administration until the last blood sampling point for each period
  • Subjects who have consumed and are unable to refrain from consuming grapefruit-containing food or beverages from 48 hours prior to the first IP administration until PSV
  • Subjects who have consumed and are unable to refrain from consuming caffeine-containing food or beverages (coffee, green tea, black tea, carbonated drinks, coffee-flavored milk, energy drinks, etc.) from 24 hours prior to IP administration until the last blood sampling point for each period
  • Subjects who have done and are unable to refrain from strenuous activity from 48 hours prior to the first IP administration until PSV
  • Subjects who are planning for pregnancy or not willing to use a medically reliable forms of contraception (administration of contraceptives or transplantation of contraceptives or use of an intrauterine device, steriliaztion surgery (vasectomy or tubal ligation), and physical barriers (spermicide, condom, contraceptive diaphragm, vaginal sponge used with a cervical cap)) from the time of consent until 2 weeks after the last IP administration
  • Subjects otherwise considered ineligible for participation due to other reasons not mentioned in the inclusion/exclusion criteria at the investigator's discretion

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chungbuk National University Hospital

    Cheongju-si

Other trials in South Korea

About this study

Official title: A Phase I Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of D958 and CKD-341 in Healthy Adult Volunteers

A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-341

Read the detailed description

A Randomized, Open-label, Oral, Single-dose, 2-treatment, Replicate crossover, 4-period Stuy

Conditions
Hypertension
Being tested
CKD-341, D958
Medical subject headings
Hypertension

What participants receive

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

  • CKD-341, D958Drug

    A single dose of 1tablet under fasting condition

Study groups in NCT05921435
Study groupRoleWhat they receive
Sequence AExperimental* Period 1: D958 * Period 2: CKD-341 * Period 3: D958 * Period 4: CKD-341
Receives: Drug: CKD-341, D958
Sequence BExperimental* Period 1: CKD-341 * Period 2: D958 * Period 3: CKD-341 * Period 4: D958
Receives: Drug: CKD-341, D958

What is being measured

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

  1. area under curve(AUC) of CKD-341, D958

    Area under the CKD-341, D958 concentration in blood-time curve from zero to final

    Measured: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 144 hours

  2. Cmax of CKD-341, D958

    The maximum CKD-341, D958 concentration in blood sampling time

    Measured: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 144 hours

Timeline

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

  1. First posted27 Jun 2023
  2. Study start20 Jun 2023
  3. Primary completion1 Sep 2023
  4. Study completion15 Sep 2023

Resources

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05921435
Sponsor's protocol ID
A126_02BE2303
Acronym
CKD-341
Status last verified
Jun 2023
First submitted
18 Jun 2023
Last updated
5 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-341, D958 in people with Hypertension, 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 6 inclusion and 29 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 5 Feb 2024. 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?

area under curve(AUC) of CKD-341, D958 (time frame: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 144 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 NCT05921435.

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 5 Feb 2024.

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