Clinical trial NCT05587699: The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A
Official title: A Randomized, Open-label, Multiple-dose and Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A in Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alopecia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-10-20
Enrollment: 41
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the pharmacokinetics, pharmacodynamics, and safety of CKD-843 A in male subjects.


Eligibility criteria: Inclusion Criteria:

* Those who aged between 19 to 50
* (Part 1) Those who are diagnosed to androgenic alopecia and meet criteria BASP grade

  * M2\~M3 or C2\~C3 grade with V1\~V3 or F1\~F3
  * M1 or C1 grade with V2\~V3 or F2\~F3
* (Part 1) Those who consent to the condition write below

  * Scalp tattoo \& to cutting hair for hair evaluation
  * Maintaining hair style \& color
* (Part 2) Those who are healthy male (Regardless of alopecia)
* Those who has body weight ≥ 55kg
* 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
* (Part 1) Those who meets the conditions write below

  * alopecia areata, telogen alopecia
  * Those who has psoriasis or folliculitis or scar on hair evaluation area
  * Those who has experience of platelet-enriched plasma treatment to scarp within 24 weeks before the first administration of investigational product
  * Those who has experience of light or laser treatment to scarp within 12 weeks before the first administration of investigational product
  * Those who has experience of prophylaxis or medication of hair loss within 14 days before the first administration of investigational product
* Those who take dutasteride or finasteride within 6 month before the first administration of investigational product
* Those who has hypersensitivity to dutasteride or other 5-alpha reductase related inhibitors.

  * (Part 1) Those who has hypersensitivity to tatto ink.
* Those who have the screening(D-28\~D-2) test results write below

  * AST, ALT \> 1.5 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 has a drug abuse history within one year or positive reaction on urine drug screening test.
* Those who receive 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 \& alcohol consumption criteria.

  * Smoke: \> 10 cigarettes/day
  * Caffeine: \> 5 cups/day
  * Alcohol \> 210 g/week
* Those who take grapefruit within 7 days before the first administration of investigational product.
* Those who receive investigational product by participating in other clinical trial within 180 days before the first administration of investigational product.
* Those who donate whole blood within 60 days or apheresis within 30 days before the first administration of investigational product.
* Those who receive transfusion within 30 days before the first administration of investigational product.
* Those who are deemed inappropriate to participate in clinical trial by investigators.

Primary outcomes:
measure: AUC0 to Day 271
timeFrame: Pre-dose(Day 1 - 0 hour), Day 1 - 4 hours, Day 2, Day 8, Day 15, Day 30, Day 46, Day 61, Day 91, Day 91 - 4 hours, Day 92, Day 98, Day 105, Day 121, Day 136, Day 151, Day 181, Day 181 4 hours, Day 182, Day 188, Day 195, Day 211, Day 226, Day 241, Day 271
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Minsoo Park, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: