A Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843

NCT ID: NCT04805606

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2021-12-24

Brief Summary

A Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843

Detailed Description

A Randomized, Open-label, and Parallel Study to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843 in Male Volunteers

Conditions

Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence 1

CKD-843 A - 27mg, Single Dose

Group Type: EXPERIMENTAL

CKD-843 A

Intervention Type: DRUG

Single Dose

Sequence 2

CKD-843 A - 45mg, Single Dose

Group Type: EXPERIMENTAL

CKD-843 A

Intervention Type: DRUG

Single Dose

Sequence 3

CKD-843 A - 56mg, Single Dose

Group Type: EXPERIMENTAL

CKD-843 A

Intervention Type: DRUG

Single Dose

Sequence 4

CKD-843 B - 45mg, Single Dose

Group Type: EXPERIMENTAL

CKD-843 B

Intervention Type: DRUG

Single Dose

Sequence 5

CKD-843-R

Group Type: ACTIVE_COMPARATOR

CKD-843-R

Intervention Type: DRUG

QD, PO

Interventions

CKD-843 A

Single Dose

Intervention Type: DRUG

CKD-843 B

Single Dose

Intervention Type: DRUG

CKD-843-R

QD, PO

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Those who aged between 19 to 50 inclusion of man who concerned about androgenic alopecia.
• Those who has body weight ≥ 50kg.
• Those who has calculated body mass index(BMI) of 18.5 ≤ ~ < 27.0 kg/m2

• Body Mass Index, kg/m2= Body weight(kg)/[Height(m)2]
• Those who consent to proper contraception and do not donate sperm until 6 months after the last administration of investigational product.
• Those who understanding the detailed description of this clinical trial and voluntarily decide to participate.

Exclusion Criteria

• Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Hemato-oncology disorder, Cardiovascular disorder or Psychical disorder
• Those who have history of hypersensitivity to active pharmaceutical ingredient, 5α-reductase inhibitor, tocopherol.
• Those who have the screening(D-28~D-2) test results written below

• AST, ALT > 1.25 times higher than upper normal level
• Total bilirubin > 1.5 times higher than upper normal level
• 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, RPR
• Under 5 min resting condition, systolic blood pressure >150 mmHg or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg
• Those who have a drug abuse history within one year or positive reaction on urine drug screening test.
• Those who received following drugs, which may affect results of clinical trial and safety Ethical-the-counter (ETC) drugs and herbal medicines within 14 days before the first administration and Over-the-counter (OTC) drugs, health foods and vitamin preparations within 7 days before the first administration of the investigational product.
• Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 30 days before the first administration of investigational product.
• Those who exceeding smoke consumption criteria or can't stop smoking during hospitalization period.

• Criteria: Smoke > 10 cigarettes/day
• Those who exceeding an alcohol and caffeine consumption criteria or can't stop consuming alcohol and caffeine during hospitalization period.

• Criteria: Caffeine > 5 cups/day, Alcohol > 210 g/week
• Those who took grapefruit within 7 days before the first administration of investigational product.
• Those who received investigational product by participating in other clinical trial within 6 months before the first administration of investigational product.
• Those who donated whole blood within 60 days or apheresis within 30 days before the first administration of investigational product.
• Those who received transfusion within 30 days before the first administration of investigational product.
• Those who are deemed inappropriate to participate in clinical trial by investigators.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MinSoo Park, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

A107_01PK2012

Identifier Type: -

Identifier Source: org_study_id