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

NCT06110923 | Completed Phase 1

• 1 other identifier: A133_01PK2306
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Benign Prostate Hypertrophy(BPH)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (5)

A1 (Test group)

EXPERIMENTAL

CKD-846 A, Single dose

Drug: CKD-846

R (Reference group)

EXPERIMENTAL

D091, Multi dose

Drug: D091

A2 (Test group)

EXPERIMENTAL

CKD-846 A, Single dose

Drug: CKD-846

B2 (Test group)

EXPERIMENTAL

CKD-846 B, Single dose

Drug: CKD-846

A3 or B3 (Test group)

EXPERIMENTAL

CKD-846 A or B, Single dose

Drug: CKD-846

Interventions

CKD-846 DRUG

once administration of Investigational Product

Also known as: Investigational Product(Test)

A1 (Test group); A2 (Test group); A3 or B3 (Test group); B2 (Test group)

D091 DRUG

once administration of Investigational Product per day

Also known as: Investigational Product(Reference)

R (Reference group)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: November 1, 2023
• Study Start: November 13, 2023
• Primary Completion: May 10, 2024
• Study Completion: March 25, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)