NCT04401137

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2020

Completed
Last Updated

October 27, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

May 14, 2020

Last Update Submit

October 23, 2020

Conditions

Migraine

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR
Drug: Topiramate

QDX 25

EXPERIMENTAL
Drug: Topiramate

QDX 50

EXPERIMENTAL
Drug: Topiramate

QDX 100

EXPERIMENTAL
Drug: Topiramate

QDX 200

EXPERIMENTAL
Drug: Topiramate

Interventions

TopiramateDRUG

Topiramate

PlaceboQDX 100QDX 200QDX 25QDX 50

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital, Dept. of Clinical Pharmacology

Seoul, South Korea

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 26, 2020

Study Start

July 1, 2020

Primary Completion

October 6, 2020

Study Completion

October 6, 2020

Last Updated

October 27, 2020

Record last verified: 2020-05

Locations

KR(1)