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

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ClinicalTrials.gov Identifier: NCT04805606
Recruitment Status : Not yet recruiting
First Posted : March 18, 2021
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Alopecia Drug: CKD-843 A Drug: CKD-843 B Drug: CKD-843-R Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, and Parallel Study to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843 in Male Volunteers
Estimated Study Start Date : April 3, 2021
Estimated Primary Completion Date : November 21, 2021
Estimated Study Completion Date : February 18, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. AUClast of CKD-843 A, CKD-843 B [ Time Frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) ]
    Area under the concentration-time curve from time zero to last

  2. AUCinf of CKD-843 A, CKD-843 B [ Time Frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) ]
    Area under the concentration-time curve from zero up to ∞

  3. AUC0-90days of CKD-843 A, CKD-843 B [ Time Frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) ]
    Area under the concentration-time curve from time zero to 90 days

  4. AUClast of CKD-843-R [ Time Frame: 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

  5. AUCinf of CKD-843-R [ Time Frame: 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 ∞

  6. AUC0-90days of CKD-843-R [ Time Frame: 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


Secondary Outcome Measures :
  1. Tmax of CKD-843 A, CKD-843 B [ Time Frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) ]
    Time to maximum plasma concentration

  2. t1/2 of CKD-843 A, CKD-843 B [ Time Frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) ]
    Terminal elimination half-life

  3. CL/F of CKD-843 A, CKD-843 B [ Time Frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) ]
    Apparent clearance

  4. Vd/F of CKD-843 A, CKD-843 B [ Time Frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) ]
    Apparent volume of distribution

  5. Tmax of CKD-843-R [ Time Frame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) ]
    Time to maximum plasma concentration

  6. t1/2 of CKD-843-R [ Time Frame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) ]
    Terminal elimination half-life

  7. CL/F of CKD-843-R [ Time Frame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) ]
    Apparent clearance

  8. Vd/F of CKD-843-R [ Time Frame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) ]
    Apparent volume of distribution



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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04805606


Contacts
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Contact: MinSoo Park, M.D. Ph.D +82-2-2228-0400 minspark@yuhs.ac

Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Contact: Minsoo Park    (82-2) 2228-0400    minspark@yuhs.ac   
Principal Investigator: Minsoo Park, M.D. Ph.D         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: MinSoo Park, M.D. Ph.D Severance Hospital
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT04805606    
Other Study ID Numbers: A107_01PK2012
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical