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this record recently (last verified Jun 2022), so the status shown — last known as Active, not recruiting — may be out of date.

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Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

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.

02

Conditions studied

  • Ataxia Telangiectasia

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03

In context

Ataxia Telangiectasia

42 studies on the registry are indexed under Ataxia Telangiectasia; 7 are open to participants now.

This study's enrollment of 48 is above the median of 30 across 28 interventional studies indexed under Ataxia Telangiectasia.

Browse Ataxia Telangiectasia studies →

Lead sponsor

Grace Therapeutics Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy male and female subjects between the ages of 18 and 55 years, inclusive.
  2. Willing and able to provide written 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. (BMI) between 18 and 32 kg/m2, inclusive, and body weight between 40 and 120 kg, inclusive.

Exclusion criteria

Exclusion Criteria:

  1. Has a history of or current 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, 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

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

06

What researchers measure

Primary outcomes

  1. AUC from 0 to 72 hours post-dose

    Area under the curve

    Time frame: Up to 72 hours post-dose

  2. AUC

    Area under the curve

    Time frame: Up to infinity

  3. Cmax from 0 to 72 hours post-dose

    Maximum concentration

    Time frame: Up to 72 hours post-dose

Secondary outcomes

  1. Adverse Events from Day 1 to Day 45

    Adverse events

    Time frame: Day 1 to Day 45

  2. 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

  3. 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

07

Study locations

1 site
  • Clinical Research Unit
    Toronto, Ontario, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2022 to primary completion in Nov 2022, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2022
First posted
Sep 8, 2022
StartActual
Sep 13, 2022
Primary completionActual
Nov 24, 2022
CompletionEst.
May 3, 2023
Last update
Jan 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

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