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CompletedNCT04805606Updated Apr 6, 2022

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

A Phase 1 interventional study of CKD-843 A and CKD-843 B in Alopecia, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-06.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
Male
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Alopecia

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03

In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's enrollment of 40 is below the median of 45 across 513 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Sequence 1

    CKD-843 A - 27mg, Single Dose

    Drug: CKD-843 A

  • Experimental
    Sequence 2

    CKD-843 A - 45mg, Single Dose

    Drug: CKD-843 A

  • Experimental
    Sequence 3

    CKD-843 A - 56mg, Single Dose

    Drug: CKD-843 A

  • Experimental
    Sequence 4

    CKD-843 B - 45mg, Single Dose

    Drug: CKD-843 B

  • Active comparator
    Sequence 5

    CKD-843-R

    Drug: CKD-843-R

Interventions

  • DrugCKD-843 A

    Single Dose

  • DrugCKD-843 B

    Single Dose

  • DrugCKD-843-R

    QD, PO

06

What researchers measure

Primary outcomes

  1. AUClast of CKD-843 A, CKD-843 B

    Area under the concentration-time curve from time zero to last

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

  2. AUCinf of CKD-843 A, CKD-843 B

    Area under the concentration-time curve from zero up to ∞

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

  3. AUC0-90days of CKD-843 A, CKD-843 B

    Area under the concentration-time curve from time zero to 90 days

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

  4. AUClast of CKD-843-R

    Area under the concentration-time curve from time zero to last

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

  5. AUCinf of CKD-843-R

    Area under the concentration-time curve from zero up to ∞

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

  6. AUC0-90days of CKD-843-R

    Area under the concentration-time curve from time zero to 90 days

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

Secondary outcomes

  1. Tmax of CKD-843 A, CKD-843 B

    Time to maximum plasma concentration

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

  2. t1/2 of CKD-843 A, CKD-843 B

    Terminal elimination half-life

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

  3. CL/F of CKD-843 A, CKD-843 B

    Apparent clearance

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

  4. Vd/F of CKD-843 A, CKD-843 B

    Apparent volume of distribution

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

  5. Tmax of CKD-843-R

    Time to maximum plasma concentration

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

  6. t1/2 of CKD-843-R

    Terminal elimination half-life

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

  7. CL/F of CKD-843-R

    Apparent clearance

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

  8. Vd/F of CKD-843-R

    Apparent volume of distribution

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

07

Study locations

1 site
  • Severance Hospital
    Seoul, 120-752, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04805606
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Mar 18, 2021
Start date
Apr 30, 2021
Primary completion
Dec 24, 2021
Completion
Dec 24, 2021
Last update
Apr 6, 2022

Study contacts

MinSoo Park, M.D. Ph.D
principal investigator · Severance Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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