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

Phase 1

Completed

• Conditions: Alopecia
• Interventions: Drug: CKD-843 A; Drug: CKD-843 B; Drug: CKD-843-R

• Registration Number: NCT04805606
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Study Start: 2021-04-30
• Primary Completion: 2021-12-24
• Study Completion: 2021-12-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequence 1	CKD-843 A	CKD-843 A - 27mg, Single Dose
Sequence 2	CKD-843 A	CKD-843 A - 45mg, Single Dose
Sequence 3	CKD-843 A	CKD-843 A - 56mg, Single Dose
Sequence 4	CKD-843 B	CKD-843 B - 45mg, Single Dose
Sequence 5	CKD-843-R	CKD-843-R

Primary Outcome Measures

Name	Time	Method
AUClast of CKD-843 A, CKD-843 B	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)	Area under the concentration-time curve from time zero to last
AUCinf of CKD-843 A, CKD-843 B	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)	Area under the concentration-time curve from zero up to ∞
AUC0-90days of CKD-843 A, CKD-843 B	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)	Area under the concentration-time curve from time zero to 90 days
AUC0-90days of CKD-843-R	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)	Area under the concentration-time curve from time zero to 90 days
AUClast of CKD-843-R	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)	Area under the concentration-time curve from time zero to last
AUCinf of CKD-843-R	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)	Area under the concentration-time curve from zero up to ∞

Secondary Outcome Measures

Name	Time	Method
Tmax of CKD-843 A, CKD-843 B	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)	Time to maximum plasma concentration
t1/2 of CKD-843 A, CKD-843 B	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)	Terminal elimination half-life
CL/F of CKD-843 A, CKD-843 B	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)	Apparent clearance
Vd/F of CKD-843-R	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)	Apparent volume of distribution
Vd/F of CKD-843 A, CKD-843 B	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)	Apparent volume of distribution
Tmax of CKD-843-R	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)	Time to maximum plasma concentration
t1/2 of CKD-843-R	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)	Terminal elimination half-life
CL/F of CKD-843-R	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)	Apparent clearance

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of