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.
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
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
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- 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.
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
- Conditions
- Benign Prostate Hypertrophy(BPH)
- 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 group | Role | What they receive |
|---|---|---|
| A1 (Test group) | Experimental | CKD-846 A, Single dose Receives: Drug: CKD-846 |
| R (Reference group) | Experimental | D091, Multi dose Receives: Drug: D091 |
| A2 (Test group) | Experimental | CKD-846 A, Single dose Receives: Drug: CKD-846 |
| B2 (Test group) | Experimental | CKD-846 B, Single dose Receives: Drug: CKD-846 |
| A3 or B3 (Test group) | Experimental | CKD-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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted1 Nov 2023
- Study start13 Nov 2023
- Primary completion10 May 2024
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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