Status unknownNCT05531890Updated Jan 23, 2023

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

A Phase 1 interventional study of GTX-102 medium dose fast Period 1 and Period 2 and GTX-102 medium dose slow Period 1 and Period 2 in Ataxia Telangiectasia, sponsored by Grace Therapeutics Inc.. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-23.

Sponsored by Grace Therapeutics Inc. · Phase 1, Interventional, and Other

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 1
Study type: Interventional
Enrollment: 48
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

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 studied

Ataxia Telangiectasia

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Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy male and female subjects between the ages of 18 and 55 years, inclusive.
Willing and able to provide written informed consent prior to participating in the study.
Able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and understand study procedures.
Able to complete all screening period evaluations, and stay in the clinic testing facility for up to 2 consecutive days on 2 separate occasions.
Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and body weight between 40 and 120 kg, inclusive.

Exclusion criteria

Exclusion Criteria:

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.
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.
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

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 48 participants (actual)

Study arms

Experimental
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
Drug: GTX-102 medium dose fast Period 1 and Period 2 · Drug: GTX-102 medium dose slow Period 1 and Period 2
Experimental
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
Drug: GTX-102 high dose fast Period 1 and Period 2
Active comparator
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
Drug: Betamethasone Oral Solution Period 1 and Period 2
Experimental
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
Drug: GTX-102 high dose fast Period 1 and Period 2 · Drug: GTX-102 low dose fast Period 1 and Period 2
Experimental
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
Drug: GTX-102 high dose fast Period 1 and Period 2
Active comparator
Group 4b betamethasone intramuscular in Period 1 and Period 2
0.1 mg/kg betamethasone solution as intramuscular injection administered over two periods
Drug: Betamethasone solution as intramuscular injection Period 1 and Period 2

Interventions

DrugGTX-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
DrugGTX-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
DrugGTX-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
DrugGTX-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
DrugBetamethasone solution as intramuscular injection Period 1 and Period 2
reference product 0.1 mg/kg betamethasone solution as an intramuscular injection
DrugBetamethasone Oral Solution Period 1 and Period 2
Comparator product 0.1 mg/kg betamethasone oral drops solution

What researchers measure

Primary outcomes

AUC from 0 to 72 hours post-dose
Area under the curve
Time frame: Up to 72 hours post-dose
AUC
Area under the curve
Time frame: Up to infinity
Cmax from 0 to 72 hours post-dose
Maximum concentration
Time frame: Up to 72 hours post-dose

Secondary outcomes

Adverse Events from Day 1 to Day 45
Adverse events
Time frame: Day 1 to Day 45
Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection
Area under the curve (AUC0-t)
Time frame: Up to 72 hours post-dose
Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection
Area under the curve (AUC0-inf)
Time frame: Up to infinity

Study locations

1 site

Clinical Research Unit
Toronto, Ontario, Canada

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT05531890
Lead sponsor: Grace Therapeutics Inc.
Responsible party: Sponsor
First posted: Sep 8, 2022
Start date: Sep 13, 2022
Primary completion: Nov 24, 2022
Completion: May 3, 2023 (estimated)
Last update: Jan 23, 2023

Study contacts

Janice Faulknor, MD

principal investigator · Clinical Research Unit

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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