GTX-102 medium dose slow Period 1 and Period 2 for Ataxia Telangiectasia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ataxia Telangiectasia+1 More
GTX-102 medium dose slow Period 1 and Period 2 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is designed to study the bioavailability, pharmacokinetics and safety of GTX-102 given as an oral spray compared to an intramuscular injection and an oral solution of betamethasone in healthy subjects.

Eligible Conditions
  • Ataxia Telangiectasia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: Up to infinity

Day 45
Adverse Events from Day 1 to Day 45
Hour 72
AUC from 0 to 72 hours post-dose
Cmax from 0 to 72 hours post-dose
Up to infinity
AUC
Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection

Trial Safety

Trial Design

6 Treatment Groups

Group 2b Oral comparator in Period 1 and Period 2
1 of 6
Group 4b betamethasone intramuscular in Period 1 and Period 2
1 of 6
Group 3 GTX-102 high dose fast or low dose fast in Period 1 and Period 2
1 of 6
Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2
1 of 6
Group 2a GTX-102 high dose fast in Period 1 and Period 2
1 of 6
Group 4a GTX-102 high dose fast in Period 1 and Period 2
1 of 6
Active Control
Experimental Treatment

48 Total Participants · 6 Treatment Groups

Primary Treatment: GTX-102 medium dose slow Period 1 and Period 2 · No Placebo Group · Phase 1

Group 3 GTX-102 high dose fast or low dose fast in Period 1 and Period 2Experimental Group · 2 Interventions: GTX-102 high dose fast Period 1 and Period 2, GTX-102 low dose fast Period 1 and Period 2 · Intervention Types: Drug, Drug
Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2Experimental Group · 2 Interventions: GTX-102 medium dose fast Period 1 and Period 2, GTX-102 medium dose slow Period 1 and Period 2 · Intervention Types: Drug, Drug
Group 2a GTX-102 high dose fast in Period 1 and Period 2
Drug
Experimental Group · 1 Intervention: GTX-102 high dose fast Period 1 and Period 2 · Intervention Types: Drug
Group 4a GTX-102 high dose fast in Period 1 and Period 2
Drug
Experimental Group · 1 Intervention: GTX-102 high dose fast Period 1 and Period 2 · Intervention Types: Drug
Group 2b Oral comparator in Period 1 and Period 2
Drug
ActiveComparator Group · 1 Intervention: Betamethasone Oral Solution Period 1 and Period 2 · Intervention Types: Drug
Group 4b betamethasone intramuscular in Period 1 and Period 2
Drug
ActiveComparator Group · 1 Intervention: Betamethasone solution as intramuscular injection Period 1 and Period 2 · 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: up to infinity

Who is running the clinical trial?

Acasti Pharma Inc.Lead Sponsor
6 Previous Clinical Trials
1,511 Total Patients Enrolled
Janice Faulknor, MDPrincipal InvestigatorClinical Research Unit
1 Previous Clinical Trials
39 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 18 and 55 years, inclusive.
You are willing and able to provide written informed consent prior to participating in the study.
You are able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and understand study procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: October 3rd, 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.