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

NCT05531890 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-01-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Grace Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Janice Faulknor, MD · Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2022-11-24
Completion
2023-05-03
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05531890 on ClinicalTrials.gov