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

Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04805606
• Other study ID #: A107_01PK2012
• Status: Completed
• Phase: Phase 1
• Start date: April 30, 2021
• Est. completion date: December 24, 2021

Study information

• Verified date: April 2022
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 24, 2021
• Est. primary completion date: December 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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, 5a-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.

Related Conditions & MeSH terms

• Alopecia

Intervention

Drug:
• CKD-843 A
Single Dose
• CKD-843 B
Single Dose
• CKD-843-R
QD, PO

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast of CKD-843 A, CKD-843 B	Area under the concentration-time curve from time zero to last	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
Primary	AUCinf of CKD-843 A, CKD-843 B	Area under the concentration-time curve from zero up to 8	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
Primary	AUC0-90days of CKD-843 A, CKD-843 B	Area under the concentration-time curve from time zero to 90 days	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
Primary	AUClast of CKD-843-R	Area under the concentration-time curve from time zero to last	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
Primary	AUCinf of CKD-843-R	Area under the concentration-time curve from zero up to 8	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
Primary	AUC0-90days of CKD-843-R	Area under the concentration-time curve from time zero to 90 days	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
Secondary	Tmax of CKD-843 A, CKD-843 B	Time to maximum plasma concentration	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
Secondary	t1/2 of CKD-843 A, CKD-843 B	Terminal elimination half-life	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
Secondary	CL/F of CKD-843 A, CKD-843 B	Apparent clearance	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
Secondary	Vd/F of CKD-843 A, CKD-843 B	Apparent volume of distribution	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
Secondary	Tmax of CKD-843-R	Time to maximum plasma concentration	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
Secondary	t1/2 of CKD-843-R	Terminal elimination half-life	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
Secondary	CL/F of CKD-843-R	Apparent clearance	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
Secondary	Vd/F of CKD-843-R	Apparent volume of distribution	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)