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

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

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

Study Overview

• Status: Completed
• Conditions: Alopecia
• Intervention / Treatment: Drug: CKD-843 A; Drug: CKD-843 B; Drug: CKD-843-R

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; CKD-843 A - 27mg, Single Dose	Drug: CKD-843 A; Single Dose
Experimental: Sequence 2; CKD-843 A - 45mg, Single Dose	Drug: CKD-843 A; Single Dose
Experimental: Sequence 3; CKD-843 A - 56mg, Single Dose	Drug: CKD-843 A; Single Dose
Experimental: Sequence 4; CKD-843 B - 45mg, Single Dose	Drug: CKD-843 B; Single Dose
Active Comparator: Sequence 5; CKD-843-R	Drug: CKD-843-R; QD, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
AUCinf of CKD-843 A, CKD-843 B	Area under the concentration-time curve from zero up to ∞	Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
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)
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)
AUCinf of CKD-843-R	Area under the concentration-time curve from zero up to ∞	Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: MinSoo Park, M.D. Ph.D, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): December 24, 2021
• Study Completion (Actual): December 24, 2021

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: A107_01PK2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No