Ataxia TelangiectasiaPhase 1NCT05531890
Comparative Bioavailability of Betamethasone Oral Solution Metered Spray (GTX-102) in Healthy Subjects
A Phase 1 study testing GTX-102 medium dose fast Period 1 and Period 2, GTX-102 medium dose slow Period 1 and Period 2 and GTX-102 high dose fast Period 1 and Period 2 in people with Ataxia Telangiectasia, run by Grace Therapeutics Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ataxia Telangiectasia
- What is being tested?
- GTX-102 medium dose fast Period 1 and Period 2, GTX-102 medium dose slow Period 1 and Period 2 and GTX-102 high dose fast Period 1 and Period 2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 13 Sep 2022to 3 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- GTX-102 medium dose fast Period 1 and Period 2, GTX-102 medium dose slow Period 1 and Period 2, GTX-102 high dose fast Period 1 and Period 2, GTX-102 low dose fast Period 1 and Period 2, Betamethasone solution as intramuscular injection Period 1 and Period 2
- Medical subject headings
- Ataxia Telangiectasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTX-102 medium dose fast Period 1 and Period 2Drug
GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered in Period 1 and Period 2 fast
GTX-102 medium dose slow Period 1 and Period 2Drug
GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered in Period 1 and Period 2 slow
GTX-102 high dose fast Period 1 and Period 2Drug
GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered in Period 1 and Period 2 fast
GTX-102 low dose fast Period 1 and Period 2Drug
GTX-102 Betamethasone oral spray high dose (0.025 mg/kg) administered in Period 1 and Period 2 fast
Betamethasone solution as intramuscular injection Period 1 and Period 2Drug
reference product 0.1 mg/kg betamethasone solution as an intramuscular injection
Betamethasone Oral Solution Period 1 and Period 2Drug
Comparator product 0.1 mg/kg betamethasone oral drops solution
| Study group | Role | What they receive |
|---|---|---|
| Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2 | Experimental | GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered fast or slow over two periods Receives: Drug: GTX-102 medium dose fast Period 1 and Period 2; Drug: GTX-102 medium dose slow Period 1 and Period 2 |
| Group 2a GTX-102 high dose fast in Period 1 and Period 2 | Experimental | GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods
Note: Note under US IND Receives: Drug: GTX-102 high dose fast Period 1 and Period 2 |
| Group 2b Oral comparator in Period 1 and Period 2 | Active comparator | 0.1 mg/kg betamethasone solution oral drops solution over two periods
Note: Not under US IND Receives: Drug: Betamethasone Oral Solution Period 1 and Period 2 |
| Group 3 GTX-102 high dose fast or low dose fast in Period 1 and Period 2 | Experimental | 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 Receives: Drug: GTX-102 high dose fast Period 1 and Period 2; Drug: GTX-102 low dose fast Period 1 and Period 2 |
| Group 4a GTX-102 high dose fast in Period 1 and Period 2 | Experimental | GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods Receives: Drug: GTX-102 high dose fast Period 1 and Period 2 |
| Group 4b betamethasone intramuscular in Period 1 and Period 2 | Active comparator | 0.1 mg/kg betamethasone solution as intramuscular injection administered over two periods Receives: Drug: Betamethasone solution as intramuscular injection Period 1 and Period 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC from 0 to 72 hours post-dose
Area under the curve
Measured: Up to 72 hours post-dose
AUC
Area under the curve
Measured: Up to infinity
Cmax from 0 to 72 hours post-dose
Maximum concentration
Measured: Up to 72 hours post-dose
Secondary outcomes (3)
Adverse Events from Day 1 to Day 45
Adverse events
Measured: 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)
Measured: 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)
Measured: Up to infinity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start13 Sep 2022
- Primary completion24 Nov 2022
- Study completion3 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ataxia TelangiectasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grace Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janice Faulknor, MD, Principal investigator, Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531890
- Sponsor's protocol ID
- GTX-102-001
- Status last verified
- Jun 2022
- First submitted
- 31 Aug 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05531890
- Acronym / sponsor ID
- GTX-102-001
- Conditions
- Ataxia Telangiectasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Grace Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 24 Nov 2022 (actual)
- Study completion
- 3 May 2023 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2 | Experimental | Drug: GTX-102 medium dose fast Period 1 and Period 2, Drug: GTX-102 medium dose slow Period 1 and Period 2GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered fast or slow over two periods |
| Group 2a GTX-102 high dose fast in Period 1 and Period 2 | Experimental | Drug: GTX-102 high dose fast Period 1 and Period 2GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods Note: Note under US IND |
| Group 2b Oral comparator in Period 1 and Period 2 | Active comparator | Drug: Betamethasone Oral Solution Period 1 and Period 20.1 mg/kg betamethasone solution oral drops solution over two periods Note: Not under US IND |
| Group 3 GTX-102 high dose fast or low dose fast in Period 1 and Period 2 | Experimental | Drug: GTX-102 high dose fast Period 1 and Period 2, Drug: GTX-102 low dose fast Period 1 and Period 2GTX-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 |
| Group 4a GTX-102 high dose fast in Period 1 and Period 2 | Experimental | Drug: GTX-102 high dose fast Period 1 and Period 2GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods |
| Group 4b betamethasone intramuscular in Period 1 and Period 2 | Active comparator | Drug: Betamethasone solution as intramuscular injection Period 1 and Period 20.1 mg/kg betamethasone solution as intramuscular injection administered over two periods |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTX-102 medium dose fast Period 1 and Period 2GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered in Period 1 and Period 2 fast | Drug | Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2 |
| GTX-102 medium dose slow Period 1 and Period 2GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered in Period 1 and Period 2 slow | Drug | Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2 |
| GTX-102 high dose fast Period 1 and Period 2GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered in Period 1 and Period 2 fast | Drug | Group 2a GTX-102 high dose fast in Period 1 and Period 2, Group 3 GTX-102 high dose fast or low dose fast in Period 1 and Period 2, Group 4a GTX-102 high dose fast in Period 1 and Period 2 |
| GTX-102 low dose fast Period 1 and Period 2GTX-102 Betamethasone oral spray high dose (0.025 mg/kg) administered in Period 1 and Period 2 fast | Drug | Group 3 GTX-102 high dose fast or low dose fast in Period 1 and Period 2 |
| Betamethasone solution as intramuscular injection Period 1 and Period 2reference product 0.1 mg/kg betamethasone solution as an intramuscular injection | Drug | Group 4b betamethasone intramuscular in Period 1 and Period 2 |
| Betamethasone Oral Solution Period 1 and Period 2Comparator product 0.1 mg/kg betamethasone oral drops solution | Drug | Group 2b Oral comparator in Period 1 and Period 2 |
Primary outcome
AUC from 0 to 72 hours post-dose
Time frame: Up to 72 hours post-dose
Area under the curve
AUC
Time frame: Up to infinity
Area under the curve
Cmax from 0 to 72 hours post-dose
Time frame: Up to 72 hours post-dose
Maximum concentration
3 secondary outcomes
Adverse Events from Day 1 to Day 45
Time frame: Day 1 to Day 45
Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection
Time frame: Up to 72 hours post-dose
Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection
Time frame: Up to infinity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Faulknor, MD principal investigator
Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GTX-102 medium dose fast Period 1 and Period 2, GTX-102 medium dose slow Period 1 and Period 2 and GTX-102 high dose fast Period 1 and Period 2 in people with Ataxia Telangiectasia, run by Grace Therapeutics Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC from 0 to 72 hours post-dose (time frame: Up to 72 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.