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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Group 4a GTX-102 high dose fast in Period 1 and Period 2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTX-102 medium dose fast Period 1 and Period 2 | Drug | GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered in Period 1 and Period 2 fast |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC from 0 to 72 hours post-dose | Area under the curve | Up to 72 hours post-dose |
| AUC | Area under the curve | Up to infinity |
| Cmax from 0 to 72 hours post-dose | Maximum concentration | Up to 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events from Day 1 to Day 45 | Adverse events | Day 1 to Day 45 |
| Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice Faulknor, MD | Clinical Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Unit | Toronto | Ontario | Canada |
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GTX-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 | 0.1 mg/kg betamethasone solution as intramuscular injection administered over two periods |
|
| GTX-102 medium dose slow Period 1 and Period 2 | Drug | 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 2 | Drug | 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 2 | Drug | 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 2 | Drug | reference product 0.1 mg/kg betamethasone solution as an intramuscular injection |
|
| Betamethasone Oral Solution Period 1 and Period 2 | Drug | Comparator product 0.1 mg/kg betamethasone oral drops solution |
|
Area under the curve (AUC0-t)
| 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) | Up to infinity |
| ID | Term |
|---|---|
| D001260 | Ataxia Telangiectasia |
| ID | Term |
|---|---|
| D020754 | Spinocerebellar Ataxias |
| D002524 | Cerebellar Ataxia |
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020752 | Neurocutaneous Syndromes |
| D001259 | Ataxia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D013684 | Telangiectasis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000081207 | Primary Immunodeficiency Diseases |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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