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

October 23, 2020 updated by: SK Chemicals Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of
        • Seoul National University Hospital, Dept. of Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Topiramate
Experimental: QDX 25
Topiramate
Experimental: QDX 50
Topiramate
Experimental: QDX 100
Topiramate
Experimental: QDX 200
Topiramate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Capsaicin-Induced Dermal Blood Flow (DBF)
Time Frame: 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
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])
Time Frame: 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.
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)
Time Frame: 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.
Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 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.
Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
Time to Reach Maximum Plasma Concentration (Tmax)
Time Frame: 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.
Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

October 6, 2020

Study Completion (Actual)

October 6, 2020

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 26, 2020

Study Record Updates

Last Update Posted (Actual)

October 27, 2020

Last Update Submitted That Met QC Criteria

October 23, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • QDX001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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