The Evaluation of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX in Healthy Korean Male Subjects

Study Overview
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Brief Summary
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To evaluate pharmacokinetic/pharmacodynamic characteristics and safety of QDX after single oral administration in healthy Korean male subjects

Official Title
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A Single Center, Randomized, Double Blind, Placebo Controlled, Dose Escalation Clinical Trial to Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX After Single Oral Administration in Healthy Korean Male Subjects

Conditions
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Migraine

Intervention / Treatment
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* Drug: Topiramate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who have fully understood this clinical trial via detailed explanation, are willing to voluntarily participate in this study, and agree to give written informed consent which is confirmed from IRB. Healthy male participants aged between 19 and 45 years at screening Those whose body weight is over 50kg, and BMI is between 18.0 and 27.0 Participants who have demonstrated at least a 100 percent (%) increase in dermal blood flow in 30 minutes after capsaicin challenge as part of the screening procedures. Exclusion Criteria: Those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system, or history of those diseases Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Topiramate etc.) Those who have a hereditary galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption syndrome Those who have irritating skin, wounds, eczema, and wounds on the area where capsaicin is applied

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Topiramate<br>* Topiramate<br>|
| Experimental: QDX 25<br> | Drug: Topiramate<br>* Topiramate<br>|
| Experimental: QDX 50<br> | Drug: Topiramate<br>* Topiramate<br>|
| Experimental: QDX 100<br> | Drug: Topiramate<br>* Topiramate<br>|
| Experimental: QDX 200<br> | Drug: Topiramate<br>* Topiramate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Capsaicin-Induced Dermal Blood Flow (DBF) | Change from Baseline in Dermal Blood Flow Induced by QDX Compared to Placebo | Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 24 hour post-dosing on Day1 | 
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]) | Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. | Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1 | 
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration (AUClast) | Area under the plasma concentration-time curve from time zero to the last quantifiable concentration. | Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1 | 
| Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. | Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1 | 
| Time to Reach Maximum Plasma Concentration (Tmax) | Tmax was defined as the time required to reach maximum observed plasma concentration. | Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1 |