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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401137
• Other study ID #: QDX001
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2020
• Est. completion date: October 6, 2020

Study information

• Verified date: May 2020
• Source: SK Chemicals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 6, 2020
• Est. primary completion date: October 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine

Intervention

Drug:
• Topiramate
Topiramate

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital, Dept. of Clinical Pharmacology	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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