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

NCT05531890 | Unknown Phase 1 FDA Drug

• 1 other identifier: GTX-102-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Adverse Events from Day 1 to Day 45

  Day 1 to Day 45

• Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection

  Up to 72 hours post-dose

• Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection

  Up to infinity

Study Arms (6)

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

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

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

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

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

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

Drug: Betamethasone solution as intramuscular injection Period 1 and Period 2

Interventions

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

Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2

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

Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2

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

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 2 DRUG

GTX-102 Betamethasone oral spray high dose (0.025 mg/kg) administered in Period 1 and Period 2 fast

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 2 DRUG

reference product 0.1 mg/kg betamethasone solution as an intramuscular injection

Group 4b betamethasone intramuscular in Period 1 and Period 2

Betamethasone Oral Solution Period 1 and Period 2 DRUG

Comparator product 0.1 mg/kg betamethasone oral drops solution

Group 2b Oral comparator in Period 1 and Period 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Grace Therapeutics Inc.: lead

Study Sites (1)

Clinical Research Unit

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Ataxia Telangiectasia

Condition Hierarchy (Ancestors)

Spinocerebellar Ataxias; Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocutaneous Syndromes; Ataxia; Dyskinesias; Neurologic Manifestations; Telangiectasis; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Primary Immunodeficiency Diseases; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Janice Faulknor, MD

  Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 8, 2022
• Study Start: September 13, 2022
• Primary Completion: November 24, 2022
• Study Completion: May 3, 2023
• Last Updated: January 23, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)