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

Sponsor

Chong Kun Dang Pharmaceutical (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06110923

Collaborator

(none)

Enrollment

Location

Arms

10.3

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Benign Prostate Hypertrophy(BPH)	Drug: CKD-846 Drug: D091	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 24, 2023

Anticipated Primary Completion Date :

Jan 16, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

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

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
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 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
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 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 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
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
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 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Chong Kun Dang Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chong Kun Dang Pharmaceutical

ClinicalTrials.gov Identifier:

NCT06110923

Other Study ID Numbers:

A133_01PK2306

First Posted:

Nov 1, 2023

Last Update Posted:

Nov 1, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Hyperplasia

Hypertrophy

Study Results

No Results Posted as of Nov 1, 2023