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

Acasti Pharma

Status and phase: Active, not recruiting; Phase 1

Conditions: Ataxia Telangiectasia

Treatments: Drug: GTX-102 medium dose slow Period 1 and Period 2; Drug: Betamethasone Oral Solution 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: GTX-102 medium dose fast Period 1 and Period 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT05531890

GTX-102-001

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 6 patient groups

Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2

Experimental group

Description:

GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered fast or slow over two periods

Treatment:

Drug: GTX-102 medium dose slow Period 1 and Period 2

Drug: GTX-102 medium dose fast Period 1 and Period 2

Group 2a GTX-102 high dose fast in Period 1 and Period 2

Experimental group

Description:

GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods Note: Note under US IND

Treatment:

Drug: GTX-102 high dose fast Period 1 and Period 2

Group 2b Oral comparator in Period 1 and Period 2

Active Comparator group

Description:

0.1 mg/kg betamethasone solution oral drops solution over two periods Note: Not under US IND

Treatment:

Drug: Betamethasone Oral Solution Period 1 and Period 2

Group 3 GTX-102 high dose fast or low dose fast in Period 1 and Period 2

Experimental group

Description:

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

Treatment:

Drug: GTX-102 high dose fast Period 1 and Period 2

Drug: GTX-102 low dose fast Period 1 and Period 2

Group 4a GTX-102 high dose fast in Period 1 and Period 2

Experimental group

Description:

GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods

Treatment:

Drug: GTX-102 high dose fast Period 1 and Period 2

Group 4b betamethasone intramuscular in Period 1 and Period 2

Active Comparator group

Description:

0.1 mg/kg betamethasone solution as intramuscular injection administered over two periods

Treatment:

Drug: Betamethasone solution as intramuscular injection Period 1 and Period 2