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

NCT ID: NCT05531890

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-13
• Study Completion Date: 2023-05-03

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.

Conditions

Ataxia Telangiectasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

GTX-102 medium dose fast Period 1 and Period 2

Intervention Type: DRUG

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

Intervention Type: DRUG

GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered in Period 1 and Period 2 slow

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

Group Type: EXPERIMENTAL

GTX-102 high dose fast Period 1 and Period 2

Intervention Type: DRUG

GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered in Period 1 and Period 2 fast

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

Group Type: ACTIVE_COMPARATOR

Betamethasone Oral Solution Period 1 and Period 2

Intervention Type: DRUG

Comparator product 0.1 mg/kg betamethasone oral drops solution

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

Group Type: EXPERIMENTAL

GTX-102 high dose fast Period 1 and Period 2

Intervention Type: DRUG

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

Intervention Type: DRUG

GTX-102 Betamethasone oral spray high dose (0.025 mg/kg) administered in Period 1 and Period 2 fast

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

Group Type: EXPERIMENTAL

GTX-102 high dose fast Period 1 and Period 2

Intervention Type: DRUG

GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered in Period 1 and Period 2 fast

Group 4b betamethasone intramuscular in Period 1 and Period 2

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

Group Type: ACTIVE_COMPARATOR

Betamethasone solution as intramuscular injection Period 1 and Period 2

Intervention Type: DRUG

reference product 0.1 mg/kg betamethasone solution as an intramuscular injection

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Betamethasone solution as intramuscular injection Period 1 and Period 2

reference product 0.1 mg/kg betamethasone solution as an intramuscular injection

Intervention Type: DRUG

Betamethasone Oral Solution Period 1 and Period 2

Comparator product 0.1 mg/kg betamethasone oral drops solution

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Grace Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janice Faulknor, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Unit

Locations

Clinical Research Unit

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

GTX-102-001

Identifier Type: -

Identifier Source: org_study_id