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

Phase 1

Recruiting

• Conditions: Benign Prostate Hypertrophy(BPH)
• Interventions: Drug: CKD-846; Drug: D091

• Registration Number: NCT06110923
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-10-19
• Study Start: 2023-10-24
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

1. Healthy man aged between 19 to 55 at screening
2. Weight ≥ 55kg
3. Body mass index (BMI) of 18.5 to 27.0kg/m2
4. 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
5. 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

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Exclusion Criteria

1. Those who have clinically significant disease or medical history of Hepatopathy, Renal, Neurological, Immunity, Respiratory, Endocrine, urinary, tumor or Psychical disorder

2. 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

3. 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

4. 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

5. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption

6. Persons with a history of clinically significant hypersensitivity to drugs or additives, including ingredients of clinical investigational drugs

7. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

8. 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.

9. Those who has a drug abuse history within one year or positive reaction on urine drug screening test.

10. 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

11. 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

12. Those who continuously smoke excessively or consume caffeine or alcohol (cigarettes: >10 cigarettes/day, caffeine: >5 cups/day, alcohol: >210 g/week)

13. 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)

14. 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)

15. Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days

16. Those who have received blood transfusion in 30 days

17. Those who are deemed insufficient to participate in clinical study by investigators

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1 (Test group)	CKD-846	CKD-846 A, Single dose
A2 (Test group)	CKD-846	CKD-846 A, Single dose
A3 or B3 (Test group)	CKD-846	CKD-846 A or B, Single dose
B2 (Test group)	CKD-846	CKD-846 B, Single dose
R (Reference group)	D091	D091, Multi dose

Primary Outcome Measures

Name	Time	Method
Plasma Concentration of CKD-846	Pre-dose, Post-dose 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 10, 24 hours (During the administration period)	Concentration of During the administration period
Concentration of D091	Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)	Concentration of During the administration period

Secondary Outcome Measures

Name	Time	Method
CKD-846 of t1/2	Pre-dose, Post-dose 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 10, 24 hours (During the administration period)	Terminal elimination half-life
CKD-846 of Vd/F	Pre-dose, Post-dose 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 10, 24 hours (During the administration period)	Apparent volume of distribution
D091 of Tmax	Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)	Time to maximum plasma concentration at steady state
CKD-846 of AUCinf	Pre-dose, Post-dose 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 10, 24 hours (During the administration period)	Area under the curve
CKD-846 of Tmax	Pre-dose, Post-dose 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 10, 24 hours (During the administration period)	Time to maximum plasma concentration
D091 of AUCt	Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)	Area under the curve
D091 of AUCinf	Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)	Area under the curve
CKD-846 of CL/F	Pre-dose, Post-dose 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 10, 24 hours (During the administration period)	Apparent clearance of drug in plasma
D091 of Cmax	Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)	Maximum concentration of drug in plasma
D091 of CL/F	Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)	Apparent clearance of drug in plasma
D091 of t1/2	Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)	Terminal elimination half-life
D091 of Vd/F	Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)	Apparent volume of distribution

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of