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Corticosteroid

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

Phase 1
Waitlist Available
Led By Janice Faulknor, 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) between 18 and 32 kg/m2, inclusive, and body weight between 40 and 120 kg, inclusive.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to infinity
Awards & highlights

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your body weight falls between 88 and 264 pounds and your BMI is between 18 and 32.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to infinity
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to infinity for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC
AUC from 0 to 72 hours post-dose
Cmax from 0 to 72 hours post-dose
Secondary outcome measures
Adverse Events from Day 1 to Day 45
Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Group 4a GTX-102 high dose fast in Period 1 and Period 2Experimental Treatment1 Intervention
GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods
Group II: Group 3 GTX-102 high dose fast or low dose fast in Period 1 and Period 2Experimental Treatment2 Interventions
GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) or GTX-102 Betamethasone oral spray low dose (0.025 mg/kg) administered fast over two periods
Group III: Group 2a GTX-102 high dose fast in Period 1 and Period 2Experimental Treatment1 Intervention
GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods Note: Note under US IND
Group IV: Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2Experimental Treatment2 Interventions
GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered fast or slow over two periods
Group V: Group 2b Oral comparator in Period 1 and Period 2Active Control1 Intervention
0.1 mg/kg betamethasone solution oral drops solution over two periods Note: Not under US IND
Group VI: Group 4b betamethasone intramuscular in Period 1 and Period 2Active Control1 Intervention
0.1 mg/kg betamethasone solution as intramuscular injection administered over two periods

Find a Location

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
Janice Faulknor, MDPrincipal InvestigatorClinical Research Unit
4 Previous Clinical Trials
113 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~19 spots leftby Mar 2025