NCT05531890View on ClinicalTrials.gov

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

PHASE1UnknownINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

September 13, 2022

Primary Completion Date

November 24, 2022

Study Completion Date

May 3, 2023

Conditions
Ataxia Telangiectasia
Interventions
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

Trial Locations (1)

Unknown

Clinical Research Unit, Toronto

Sponsors
All Listed Sponsors
lead

Grace Therapeutics Inc.

INDUSTRY