NCT05531890

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Grace Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
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
DRUG	Betamethasone solution as intramuscular injection Period 1 and Period 2	reference product 0.1 mg/kg betamethasone solution as an intramuscular injection
DRUG	Betamethasone Oral Solution Period 1 and Period 2	Comparator product 0.1 mg/kg betamethasone oral drops solution

Timeline

• Start date: 2022-09-13
• Primary completion: 2022-11-24
• Completion: 2023-05-03
• First posted: 2022-09-08
• Last updated: 2023-01-23

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study