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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostate Hypertrophy(BPH)
• Intervention / Treatment: Drug: CKD-846; Drug: D091

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: MInsoo Park, MD, PhD; Phone Number: +82-2-2228-0401; Email: MINSPARK@YUHS.AC

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital
    • Contact: MInsoo Park, MD, PhD; Phone Number: +82-2-2228-0401; Email: MINSPARK@YUHS.AC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A1 (Test group); CKD-846 A, Single dose	Drug: CKD-846; once administration of Investigational Product; Other Names: Investigational Product(Test)
Experimental: R (Reference group); D091, Multi dose	Drug: D091; once administration of Investigational Product per day; Other Names: Investigational Product(Reference)
Experimental: A2 (Test group); CKD-846 A, Single dose	Drug: CKD-846; once administration of Investigational Product; Other Names: Investigational Product(Test)
Experimental: B2 (Test group); CKD-846 B, Single dose	Drug: CKD-846; once administration of Investigational Product; Other Names: Investigational Product(Test)
Experimental: A3 or B3 (Test group); CKD-846 A or B, Single dose	Drug: CKD-846; once administration of Investigational Product; Other Names: Investigational Product(Test)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of CKD-846	Concentration of During the administration period	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	Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CKD-846 of AUCinf	Area under the curve	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	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	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	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	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	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	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	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	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	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	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	Pre-dose, Post-dose 0.5, 1, 2, 4, 6, 10, 24, 48, 72, 96 hours (During the administration period)

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Estimated): October 24, 2023
• Primary Completion (Estimated): January 16, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Prostatic Diseases; Pathological Conditions, Anatomical; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hypertrophy
• Other Study ID Numbers: A133_01PK2306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No