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GTX-101 for Postherpetic Neuralgia
Phase 1
Waitlist Available
Led By Eric Sicard, MD
Research Sponsored by Acasti Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m2, inclusively at Screening
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 0 hour to 240 hour after study drug administration
Awards & highlights
Study Summary
This trial is testing a new drug, GTX-101, to see how it compares to a current injection medication in healthy adults. Blood samples will be taken to assess the new drug's safety and how it is processed by the body.
Eligible Conditions
- Postherpetic Neuralgia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Your body mass index (BMI) falls within the range of 18.0 to 30.0 kg/m2.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 0 hour to 240 hour after study drug administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 0 hour to 240 hour after study drug administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC inf
AUC last
Cmax between 0 hour to 240 hour after study drug administration
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: 50 mg GTX-101Experimental Treatment1 Intervention
Group II: 200 mg GTX-101Experimental Treatment1 Intervention
Group III: 100 mg GTX-101Experimental Treatment1 Intervention
Group IV: Bupivacaine subcutaneous injectionActive Control1 Intervention
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Acasti Pharma Inc.Lead Sponsor
7 Previous Clinical Trials
1,416 Total Patients Enrolled
Eric Sicard, MDPrincipal InvestigatorClinical Research Unit
21 Previous Clinical Trials
849 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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