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

• ClinicalTrials.gov Identifier: NCT05531890
• Recruitment Status: Active, not recruiting
• First Posted: September 8, 2022
• Last Update Posted: January 23, 2023
• Sponsor: Acasti Pharma Inc.
• Information provided by (Responsible Party): Acasti Pharma Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Ataxia Telangiectasia	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: GTX-102 low dose fast Period 1 and Period 2; Drug: Betamethasone solution as intramuscular injection Period 1 and Period 2; Drug: Betamethasone Oral Solution Period 1 and Period 2	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: September 13, 2022
• Actual Primary Completion Date: November 24, 2022
• Estimated Study Completion Date: May 3, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. AUC from 0 to 72 hours post-dose [ Time Frame: Up to 72 hours post-dose ]
   Area under the curve
2. AUC [ Time Frame: Up to infinity ]
   Area under the curve
3. Cmax from 0 to 72 hours post-dose [ Time Frame: Up to 72 hours post-dose ]
   Maximum concentration

Secondary Outcome Measures :

1. Adverse Events from Day 1 to Day 45 [ Time Frame: Day 1 to Day 45 ]
   Adverse events
2. Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection [ Time Frame: Up to 72 hours post-dose ]
   Area under the curve (AUC0-t)
3. Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection [ Time Frame: Up to infinity ]
   Area under the curve (AUC0-inf)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

Clinical Research Unit

Toronto, Ontario, Canada

Sponsors and Collaborators

Acasti Pharma Inc.

Investigators

• Principal Investigator: Janice Faulknor, MD; Clinical Research Unit

More Information

• Responsible Party: Acasti Pharma Inc.
• ClinicalTrials.gov Identifier: NCT05531890
• Other Study ID Numbers: GTX-102-001
• First Posted: September 8, 2022
• Last Update Posted: January 23, 2023
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Ataxia Telangiectasia; Telangiectasis; Ataxia; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinocerebellar Ataxias; Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Neurocutaneous Syndromes; Genetic Diseases, Inborn; Primary Immunodeficiency Diseases; DNA Repair-Deficiency Disorders; Metabolic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Pharmaceutical Solutions; Betamethasone sodium phosphate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists