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Benign Prostate Hypertrophy(BPH)Phase 1NCT06110923

A Clinical Trial to Compare and Evaluate Evaluate the Pharmacokinetics and Safety of CKD-846

A Phase 1 study testing CKD-846 and D091 in people with Benign Prostate Hypertrophy(BPH), 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 evaluate the pharmacokinetics and safety of CKD-846 Read more about this study

Who is it for?
Ages 19 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Benign Prostate Hypertrophy(BPH)
What is being tested?
CKD-846 and D091
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteSouth Korea
Study dates
13 Nov 2023to 25 Mar 2025
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy man aged between 19 to 55 at screening
  • Weight ≥ 55kg
  • Body mass index (BMI) of 18.5 to 27.0kg/m2
  • Those who agree to contraception from the first Investigational Product (IP) dosing day till 6 months after the last dosing day and decide not to provide sperm during the participation of clinical trial
  • Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial

Who cannot join

  • Those who have clinically significant disease or medical history of Hepatopathy, Renal, Neurological, Immunity, Respiratory, Endocrine, urinary, tumor or Psychical disorder
  • Those who have a history of clinically significant cardiovascular diseases such as myocardial infarction, angina pectoris, ventricular arrhythmia, heart failure, left ventricular outflow tract stenosis, stroke, and transient ischemic attack within 2 years prior to the first administration of the investigational drug
  • Those who have had myocardial infarction within the last 90 days
  • Those who have had unstable angina or angina that occurred during sexual intercourse
  • Those who have had heart failure of New York Heart Association class 2 or higher in the past 6 months
  • Those who have had a stroke within the last 6 months
Show all 36Show fewer
  • Those with the following eye diseases
  • Those with known genetic degenerative retinal diseases, including retinitis pigmentosa
  • People who have lost vision in one eye due to non-arteritic anterior ischemic optic neuropathy
  • Those with a past history of erection lasting more than 4 hours and priapism (erection accompanied by pain for more than 6 hours) while taking PDE5 inhibitors such as tadalafil
  • Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption
  • Persons with a history of clinically significant hypersensitivity to drugs or additives, including ingredients of clinical investigational drugs
  • Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • A person who is judged to be unsuitable as a test subject in a screening test (screening items such as questionnaire, blood pressure, 12-lead ECG, physical examination, clinical laboratory test, etc.) conducted within 28 days before administration of the investigational drug
  • Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) > 1.5 times higher than upper normal level
  • Total bilirubin > 1.5 times higher than upper normal level
  • Epidermal Growth Factor Receptor (eGFR) (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2
  • "Positive" or "Reactive" test result of Hepatitis B \& C, HIV, rapid plasma reagin test (RPR) > 10.0 ng/mL
  • Prostate specific antigen (PSA)
  • Under 5 min resting condition, systolic blood pressure >150 mmHg or or <90 mmHg, diastolic blood pressure >100 mmHg or <50mmHg.
  • Those who has a drug abuse history within one year or positive reaction on urine drug screening test.
  • Those who have taken the following drugs, excluding topical drugs without significant systemic absorption, within the relevant period and it is judged that the administered drugs may affect this study or affect the safety of subjects
  • Over the counter (OTC), vitamins, health supplement within 7 days before the first dose of the investigational drug
  • Ethical drug (ETC), herbal medicinal preparations within 14 days before the first dose of the investigational drug
  • CYP3A4 inhibitors or CYP3A4 inducers within 30 days before the first dose of the investigational drug
  • Depot injection or implantation within 30 days before the first dose of the investigational drug
  • Persons who must take the following drugs regularly and/or intermittently during the clinical trial period
  • Nitrate preparations or NO donors
  • Alpha blockers
  • GC stimulators
  • Those who continuously smoke excessively or consume caffeine or alcohol (cigarettes: >10 cigarettes/day, caffeine: >5 cups/day, alcohol: >210 g/week)
  • A person who consumed food containing grapefruit within 7 days before the first administration of the investigational drug (e.g., a person who consumed more than 1L of grapefruit-containing beverages per day within 7 days before the first administration of the investigational drug)
  • Persons who participated in another clinical trial (including bioequivalence test) and received an investigational drug within 180 days prior to the date of first administration of the investigational drug (in the case of biological products, the period may be extended considering the half-life)
  • Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days
  • Those who have received blood transfusion in 30 days
  • Those who are deemed insufficient to participate in clinical study by investigators

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label and Parallel Study to Evaluate the Pharmacokinetics and Safety of CKD-846 in Healthy Male Subjects

A Clinical trial to compare and evaluate evaluate the pharmacokinetics and safety of CKD-846

Read the detailed description

A randomized, open-label and parallel study to evaluate the pharmacokinetics and safety of CKD-846 in healthy male subjects

Being tested
CKD-846, D091
Medical subject headings
Prostatic Hyperplasia

What participants receive

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

  • CKD-846Drug

    Also called Investigational Product(Test)

    once administration of Investigational Product

  • D091Drug

    Also called Investigational Product(Reference)

    once administration of Investigational Product per day

Study groups in NCT06110923
Study groupRoleWhat they receive
A1 (Test group)ExperimentalCKD-846 A, Single dose
Receives: Drug: CKD-846
R (Reference group)ExperimentalD091, Multi dose
Receives: Drug: D091
A2 (Test group)ExperimentalCKD-846 A, Single dose
Receives: Drug: CKD-846
B2 (Test group)ExperimentalCKD-846 B, Single dose
Receives: Drug: CKD-846
A3 or B3 (Test group)ExperimentalCKD-846 A or B, Single dose
Receives: Drug: CKD-846

What is being measured

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

  1. Plasma Concentration of CKD-846

    Concentration of During the administration period

    Measured: Pre-dose, Post-dose 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 10, 24 hours (During the administration period)

  2. Concentration of D091

    Concentration of During the administration period

    Measured: Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)

Secondary outcomes (12)

  1. CKD-846 of AUCinf

    Area under the curve

    Measured: Pre-dose, Post-dose 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 10, 24 hours (During the administration period)

  2. CKD-846 of Tmax

    Time to maximum plasma concentration

    Measured: Pre-dose, Post-dose 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 10, 24 hours (During the administration period)

  3. CKD-846 of t1/2

    Terminal elimination half-life

    Measured: Pre-dose, Post-dose 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 10, 24 hours (During the administration period)

  4. CKD-846 of CL/F

    Apparent clearance of drug in plasma

    Measured: Pre-dose, Post-dose 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 10, 24 hours (During the administration period)

  5. CKD-846 of Vd/F

    Apparent volume of distribution

    Measured: Pre-dose, Post-dose 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 10, 24 hours (During the administration period)

  6. D091 of Cmax

    Maximum concentration of drug in plasma

    Measured: Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)

  7. D091 of AUCt

    Area under the curve

    Measured: Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)

  8. D091 of AUCinf

    Area under the curve

    Measured: Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)

  9. D091 of Tmax

    Time to maximum plasma concentration at steady state

    Measured: Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)

  10. D091 of t1/2

    Terminal elimination half-life

    Measured: Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)

  11. D091 of CL/F

    Apparent clearance of drug in plasma

    Measured: Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)

  12. D091 of Vd/F

    Apparent volume of distribution

    Measured: Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)

Timeline

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

  1. First posted1 Nov 2023
  2. Study start13 Nov 2023
  3. Primary completion10 May 2024
  4. Study completion25 Mar 2025

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
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06110923
Sponsor's protocol ID
A133_01PK2306
Status last verified
Jan 2026
First submitted
19 Oct 2023
Last updated
14 Jan 2026
Results posted
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-846 and D091 in people with Benign Prostate Hypertrophy(BPH), 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 5 inclusion and 36 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 14 Jan 2026. 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?

Plasma Concentration of CKD-846 (time frame: Pre-dose, Post-dose 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 10, 24 hours (During the administration period)). 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 NCT06110923.

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 14 Jan 2026.

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