Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05531890
Other study ID # GTX-102-001
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date September 13, 2022
Est. completion date May 3, 2023

Study information

Verified date June 2022
Source Acasti Pharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Randomized, Open-label, Crossover Study to Evaluate the Comparative Bioavailability, Pharmacokinetics, and Safety of GTX-102 Administered as an Oral Spray Compared to Intramuscular Injection - betamethasone and an Oral Solution of Betamethasone in Healthy Subjects. Four groups of subjects will receive 2 treatments each and randomized in 2-way crossover.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 48
Est. completion date May 3, 2023
Est. primary completion date November 24, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. Healthy male and female subjects between the ages of 18 and 55 years, inclusive. 2. Willing and able to provide written informed consent prior to participating in the study. 3. Able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and understand study procedures. 4. Able to complete all screening period evaluations, and stay in the clinic testing facility for up to 2 consecutive days on 2 separate occasions. 5. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and body weight between 40 and 120 kg, inclusive. Exclusion Criteria: 1. Has a history of or current clinically significant medical illness including (but not limited to) pulmonary, cardiovascular, coagulation disorders, lipid abnormalities, gastrointestinal, immunologic, endocrine (stable thyroid hormone replacement therapy is not excluded), neurologic, psychiatric, or thromboembolic disease, metabolic disturbances, or any other current physical condition that the Investigator considers should exclude the participant, or that could interfere with the interpretation of the study results. 2. Has current or recent (within 6 months) history of gastrointestinal disease, or any surgical or medical condition such as Crohn's disease or liver disease, that could potentially alter the absorption, metabolism, or excretion of the study drug. 3. Has any clinically significant medical condition, physical examination finding, vital signs, ECG abnormality (at screening), or clinically significant abnormal value for hematology, serology, clinical chemistry, or urinalysis at screening or at admission to the study center, as deemed appropriate by the Investigator

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GTX-102 medium dose fast Period 1 and Period 2
GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered in Period 1 and Period 2 fast
GTX-102 medium dose slow Period 1 and Period 2
GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered in Period 1 and Period 2 slow
GTX-102 high dose fast Period 1 and Period 2
GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered in Period 1 and Period 2 fast
GTX-102 low dose fast Period 1 and Period 2
GTX-102 Betamethasone oral spray high dose (0.025 mg/kg) administered in Period 1 and Period 2 fast
Betamethasone solution as intramuscular injection Period 1 and Period 2
reference product 0.1 mg/kg betamethasone solution as an intramuscular injection
Betamethasone Oral Solution Period 1 and Period 2
Comparator product 0.1 mg/kg betamethasone oral drops solution

Locations

Country Name City State
Canada Clinical Research Unit Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Acasti Pharma Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUC from 0 to 72 hours post-dose Area under the curve Up to 72 hours post-dose
Primary AUC Area under the curve Up to infinity
Primary Cmax from 0 to 72 hours post-dose Maximum concentration Up to 72 hours post-dose
Secondary Adverse Events from Day 1 to Day 45 Adverse events Day 1 to Day 45
Secondary Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection Area under the curve (AUC0-t) Up to 72 hours post-dose
Secondary Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection Area under the curve (AUC0-inf) Up to infinity
See also
  Status Clinical Trial Phase
Completed NCT02345135 - Susceptibility to Infections in Ataxia Telangiectasia N/A
Active, not recruiting NCT04991701 - A National Retrospective Population Based Cohort Study of the Natural History of Ataxia Telangiectasia
Recruiting NCT05692596 - The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
Completed NCT05252819 - Whole Body MRI for Cancer Surveillance in A-T
Recruiting NCT03357978 - Susceptibility to Infections, Tumor Risk and Liver Disease in Patients With Ataxia Telangiectasia N/A
Withdrawn NCT02309632 - Pancreatic Cancer Screening of High-Risk Individuals in Arkansas N/A
Not yet recruiting NCT06324877 - Ataxia-telangiectasia: Treating Mitochondrial Dysfunction With Nicotinamide Riboside N/A
Not yet recruiting NCT01075438 - Immunogenicity of Pneumococcal Vaccines in Ataxia-telangiectasia Patients N/A
Completed NCT03962114 - Effects of Vitamin B3 in Patients With Ataxia Telangiectasia Phase 2
Completed NCT04513002 - Ataxia-telangiectasia: Treating Mitochondrial Dysfunction With a Novel Form of Anaplerosis Phase 2
Completed NCT05471310 - Videoocular Assessment of Eye Movement Activity in an Ataxia Telangiectasia
Active, not recruiting NCT04870866 - NAD Supplementation to Prevent Progressive Neurological Disease in Ataxia Telangiectasia Phase 2
Recruiting NCT06193200 - To Evaluate the Effects of EryDex in Patients With A-T Phase 3
Recruiting NCT03563053 - Open-label, Long-term, Extension Treatment Using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients With Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study Phase 3
Recruiting NCT05692622 - Home-based Complex Intervention for Children With Ataxia Telangiectasia N/A
Recruiting NCT04037189 - Treatment of Leukemia and Lymphoma in Children With Ataxia Telangiectasia
Not yet recruiting NCT04887311 - MBM-01 (Tempol) for the Treatment of Ataxia Telangiectasia Phase 2
Active, not recruiting NCT00951886 - The Validity of Forced Expiratory Maneuvers in Ataxia Telangiectasia Studied Longitudinally N/A
Recruiting NCT03759678 - N-Acetyl-L-Leucine for Ataxia-Telangiectasia (A-T) Phase 2
Recruiting NCT01052623 - Status of Growth Hormone/ Insulin-like Growth Factor-1 (GH/IGF-1) Axis and Growth Failure in Ataxia Telangiectasia (AT) Phase 4