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

Phase 1

• Conditions: Ataxia Telangiectasia
• Interventions: Drug: GTX-102 high dose fast Period 1 and Period 2; Drug: GTX-102 medium dose fast Period 1 and Period 2; Drug: Betamethasone Oral Solution Period 1 and Period 2; Drug: Betamethasone solution as intramuscular injection Period 1 and Period 2; Drug: GTX-102 low dose fast Period 1 and Period 2; Drug: GTX-102 medium dose slow Period 1 and Period 2

• Registration Number: NCT05531890
• Lead Sponsor: Acasti Pharma Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-08
• Study Start: 2022-09-13
• Primary Completion: 2022-11-24
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23
• Study Completion: 2023-05-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
AUC from 0 to 72 hours post-dose	Up to 72 hours post-dose	Area under the curve
AUC	Up to infinity	Area under the curve
Cmax from 0 to 72 hours post-dose	Up to 72 hours post-dose	Maximum concentration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Research Unit; 🇨🇦 Toronto, Ontario, Canada