- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04401137
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
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.
Sponsor
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Migraine
-
Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
-
Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
-
The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
Clinical Trials on Topiramate
-
Johnson & Johnson Taiwan LtdCompleted
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Supernus Pharmaceuticals, Inc.Completed
-
University of CopenhagenR W Johnson Pharmaceutical Research InstituteTerminated
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedObesity | Diabetes Mellitus, Type 2 | Diabetes Mellitus, Adult-Onset
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedObesity | Diabetes Mellitus, Type 2 | Diabetes Mellitus, Adult-Onset
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Janssen Pharmaceutica N.V., BelgiumCompleted
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedMigraine | Headache | Common Migraine | Classic Migraine