Clinical trial NCT04805606: A Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843
Official title: A Randomized, Open-label, and Parallel Study to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843 in Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alopecia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-03-18
Enrollment: 40
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 Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843

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

Eligibility 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.

Primary outcomes:
measure: AUClast of CKD-843 A, CKD-843 B
timeFrame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
measure: AUCinf of CKD-843 A, CKD-843 B
timeFrame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
measure: AUC0-90days of CKD-843 A, CKD-843 B
timeFrame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
measure: AUClast of CKD-843-R
timeFrame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
measure: AUCinf of CKD-843-R
timeFrame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
measure: AUC0-90days of CKD-843-R
timeFrame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
Secondary outcomes:
measure: Tmax of CKD-843 A, CKD-843 B
timeFrame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
measure: t1/2 of CKD-843 A, CKD-843 B
timeFrame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
measure: CL/F of CKD-843 A, CKD-843 B
timeFrame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
measure: Vd/F of CKD-843 A, CKD-843 B
timeFrame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
measure: Tmax of CKD-843-R
timeFrame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
measure: t1/2 of CKD-843-R
timeFrame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
measure: CL/F of CKD-843-R
timeFrame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
measure: Vd/F of CKD-843-R
timeFrame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
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: