Comparative Bioavailability of Betamethasone Oral Solution Metered Spray (GTX-102) in Healthy Subjects

Crossover Study to Evaluate the Comparative Bioavailability, Pharmacokinetics, and Safety of GTX-102 Administered as an Oral Spray Compared to Intramuscular Injection and an Oral Solution of Betamethasone 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ataxia Telangiectasia
• Intervention / Treatment: Drug: GTX-102 medium dose fast Period 1 and Period 2; Drug: GTX-102 medium dose slow Period 1 and Period 2; Drug: GTX-102 high dose fast Period 1 and Period 2; Drug: Betamethasone Oral Solution Period 1 and Period 2; Drug: GTX-102 low dose fast Period 1 and Period 2; Drug: Betamethasone solution as intramuscular injection Period 1 and Period 2

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Daniel Croteau, MSc Pharm; Phone Number: + (418) 455 4971; Email: d.croteau@acastipharma.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2; GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered fast or slow over two periods	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; Drug: 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
Experimental: Group 2a GTX-102 high dose fast in Period 1 and Period 2; GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods Note: Note under US IND	Drug: 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
Active Comparator: Group 2b Oral comparator in Period 1 and Period 2; 0.1 mg/kg betamethasone solution oral drops solution over two periods Note: Not under US IND	Drug: Betamethasone Oral Solution Period 1 and Period 2; Comparator product 0.1 mg/kg betamethasone oral drops solution
Experimental: Group 3 GTX-102 high dose fast or low dose fast in Period 1 and Period 2; 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	Drug: 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; Drug: 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
Experimental: Group 4a GTX-102 high dose fast in Period 1 and Period 2; GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods	Drug: 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
Active Comparator: Group 4b betamethasone intramuscular in Period 1 and Period 2; 0.1 mg/kg betamethasone solution as intramuscular injection administered over two periods	Drug: Betamethasone solution as intramuscular injection Period 1 and Period 2; reference product 0.1 mg/kg betamethasone solution as an intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC from 0 to 72 hours post-dose	Area under the curve	Up to 72 hours post-dose
AUC	Area under the curve	Up to infinity
Cmax from 0 to 72 hours post-dose	Maximum concentration	Up to 72 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events from Day 1 to Day 45	Adverse events	Day 1 to Day 45
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
Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection	Area under the curve (AUC0-inf)	Up to infinity

Collaborators and Investigators

• Sponsor: Acasti Pharma Inc.
• Investigators: Principal Investigator: Janice Faulknor, MD, Clinical Research Unit

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Actual): November 24, 2022
• Study Completion (Anticipated): May 3, 2023

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Dyskinesias; DNA Repair-Deficiency Disorders; Neurocutaneous Syndromes; Cerebellar Diseases; Primary Immunodeficiency Diseases; Ataxia; Spinocerebellar Ataxias; Cerebellar Ataxia; Telangiectasis; Ataxia Telangiectasia; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate; Pharmaceutical Solutions
• Other Study ID Numbers: GTX-102-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No