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

Phase 1

Completed

• Conditions: Migraine
• Interventions: Drug: Topiramate

• Registration Number: NCT04401137
• Lead Sponsor: SK Chemicals Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-26
• Study Start: 2020-07-01
• Primary Completion: 2020-10-06
• Study Completion: 2020-10-06
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Topiramate	-
QDX 25	Topiramate	-
QDX 100	Topiramate	-
QDX 50	Topiramate	-
QDX 200	Topiramate	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital, Dept. of Clinical Pharmacology; 🇰🇷 Seoul, Korea, Republic of