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

NCT04805606 | Completed Phase 1

• 1 other identifier: A107_01PK2012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alopecia

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Tmax of CKD-843 A, CKD-843 B

  Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)

• t1/2 of CKD-843 A, CKD-843 B

  Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)

• CL/F of CKD-843 A, CKD-843 B

  Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)

• Vd/F of CKD-843 A, CKD-843 B

  Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)

• Tmax of CKD-843-R

  Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)

Study Arms (5)

Sequence 1

EXPERIMENTAL

CKD-843 A - 27mg, Single Dose

Drug: CKD-843 A

Sequence 2

EXPERIMENTAL

CKD-843 A - 45mg, Single Dose

Drug: CKD-843 A

Sequence 3

EXPERIMENTAL

CKD-843 A - 56mg, Single Dose

Drug: CKD-843 A

Sequence 4

EXPERIMENTAL

CKD-843 B - 45mg, Single Dose

Drug: CKD-843 B

Sequence 5

ACTIVE COMPARATOR

CKD-843-R

Drug: CKD-843-R

Interventions

CKD-843 A DRUG

Single Dose

Sequence 1; Sequence 2; Sequence 3

CKD-843 B DRUG

Single Dose

Sequence 4

CKD-843-R DRUG

QD, PO

Sequence 5

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• MinSoo Park, M.D. Ph.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

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: March 16, 2021
• First Posted: March 18, 2021
• Study Start: April 30, 2021
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)