GTX-101 for Postherpetic Neuralgia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Clinical Research Unit, Montréal, Canada
Postherpetic Neuralgia+2 More
GTX-101 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This is a single-center, randomized, single-dose, active-controlled study in healthy male and female subjects. The study will enroll subjects to evaluate the PK of 3 dose strengths (50 mg, 100 mg and 200 mg) of GTX-101 compared to Subcutaneous injection in healthy adult subjects. Blood samples for PK assessments will be collect at specified time points. Safety assessments will also be performed throughout the study.

Eligible Conditions

  • Postherpetic Neuralgia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: From 0 hour to 240 hour after study drug administration

Hour 240
AUC inf
AUC last
Cmax between 0 hour to 240 hour after study drug administration
Tmax between 0 hour to 240 hour after study drug administration

Trial Safety

Trial Design

4 Treatment Groups

Bupivacaine subcutaneous injection
1 of 4
100 mg GTX-101
1 of 4
200 mg GTX-101
1 of 4
50 mg GTX-101
1 of 4
Active Control
Experimental Treatment

48 Total Participants · 4 Treatment Groups

Primary Treatment: GTX-101 · No Placebo Group · Phase 1

100 mg GTX-101
Drug
Experimental Group · 1 Intervention: GTX-101 · Intervention Types: Drug
200 mg GTX-101
Drug
Experimental Group · 1 Intervention: GTX-101 · Intervention Types: Drug
50 mg GTX-101
Drug
Experimental Group · 1 Intervention: GTX-101 · Intervention Types: Drug
Bupivacaine subcutaneous injection
Drug
ActiveComparator Group · 1 Intervention: Bupivacaine HCl subcutaneous injection · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from 0 hour to 240 hour after study drug administration
Closest Location: Clinical Research Unit · Montréal, Canada
2006First Recorded Clinical Trial
1 TrialsResearching Postherpetic Neuralgia
23 CompletedClinical Trials

Who is running the clinical trial?

Acasti Pharma Inc.Lead Sponsor
6 Previous Clinical Trials
1,511 Total Patients Enrolled
Eric Sicard, MDPrincipal InvestigatorClinical Research Unit
21 Previous Clinical Trials
1,044 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a healthy adult male or female, aged 18 to 55 years, inclusive, at Screening.
You have a body mass index (BMI) within 18.0 kg/m2 to 30.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.