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

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

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

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

Conditions
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Alopecia

Intervention / Treatment
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* Drug: CKD-843 A
* Drug: CKD-843 B
* Drug: CKD-843-R


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>CKD-843 A - 27mg, Single Dose | Drug: CKD-843 A<br>* Single Dose<br>|
| Experimental: Sequence 2<br>CKD-843 A - 45mg, Single Dose | Drug: CKD-843 A<br>* Single Dose<br>|
| Experimental: Sequence 3<br>CKD-843 A - 56mg, Single Dose | Drug: CKD-843 A<br>* Single Dose<br>|
| Experimental: Sequence 4<br>CKD-843 B - 45mg, Single Dose | Drug: CKD-843 B<br>* Single Dose<br>|
| Active Comparator: Sequence 5<br>CKD-843-R | Drug: CKD-843-R<br>* QD, PO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of CKD-843 A, CKD-843 B | Area under the concentration-time curve from time zero to last | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | 
| AUCinf of CKD-843 A, CKD-843 B | Area under the concentration-time curve from zero up to ∞ | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | 
| AUC0-90days of CKD-843 A, CKD-843 B | Area under the concentration-time curve from time zero to 90 days | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | 
| AUClast of CKD-843-R | Area under the concentration-time curve from time zero to last | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) | 
| AUCinf of CKD-843-R | Area under the concentration-time curve from zero up to ∞ | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) | 
| AUC0-90days of CKD-843-R | Area under the concentration-time curve from time zero to 90 days | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax of CKD-843 A, CKD-843 B | Time to maximum plasma concentration | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | 
| t1/2 of CKD-843 A, CKD-843 B | Terminal elimination half-life | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | 
| CL/F of CKD-843 A, CKD-843 B | Apparent clearance | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | 
| Vd/F of CKD-843 A, CKD-843 B | Apparent volume of distribution | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | 
| Tmax of CKD-843-R | Time to maximum plasma concentration | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) | 
| t1/2 of CKD-843-R | Terminal elimination half-life | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) | 
| CL/F of CKD-843-R | Apparent clearance | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) | 
| Vd/F of CKD-843-R | Apparent volume of distribution | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) |