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

Ataxia Telangiectasia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05531890
• Other study ID #: GTX-102-001
• Status: Active, not recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Ataxia Telangiectasia
• Telangiectasis

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