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

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Alopecia

Treatments: Drug: CKD-843 A; Drug: CKD-843 B; Drug: CKD-843-R

Study type: Interventional

Funder types: Industry

Identifiers

NCT04805606

A107_01PK2012

Details and patient eligibility

About

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

Full description

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

Enrollment: 40 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 5 patient groups

Sequence 1

Experimental group

Description:

CKD-843 A - 27mg, Single Dose

Treatment:

Drug: CKD-843 A

Sequence 2

Experimental group

Description:

CKD-843 A - 45mg, Single Dose

Treatment:

Drug: CKD-843 A

Sequence 3

Experimental group

Description:

CKD-843 A - 56mg, Single Dose

Treatment:

Drug: CKD-843 A

Sequence 4

Experimental group

Description:

CKD-843 B - 45mg, Single Dose

Treatment:

Drug: CKD-843 B

Sequence 5

Active Comparator group

Description:

CKD-843-R

Treatment:

Drug: CKD-843-R