The study of betamethasone oral solution metered spray (GTX-102) for ataxia telangiectasia in healthy subjects
Acasti Pharma Inc is recruiting patients for the clinical trial of Comparative Bioavailability of Betamethasone Oral Solution Metered Spray (GTX-102) in Healthy Subjects.
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.
The researchers plan that September 13, 2022 will be the study start date. The indicative completion of the clinical trial will be expected in November 27, 2022. Among primary outcome measures are the Cmax from 0 to 72 hours post-dose and Maximum concentration. The study will take place at the Clinical Research Unit, Toronto, Ontario, Canada.
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.
The page dedicated to this clinical trial that provides exlusion criteria and further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05531890.
