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

Primary Purpose

Ataxia Telangiectasia

Status
Active
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
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
Betamethasone Oral Solution Period 1 and Period 2
Sponsored by
Acasti Pharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ataxia Telangiectasia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  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, 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

Sites / Locations

  • Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

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

Group 2a GTX-102 high dose fast in Period 1 and Period 2

Group 2b Oral comparator 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

Group 4b betamethasone intramuscular in Period 1 and Period 2

Arm Description

GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered fast or slow over two periods

GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods Note: Note under US IND

0.1 mg/kg betamethasone solution oral drops solution over two periods Note: Not under US IND

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

GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods

0.1 mg/kg betamethasone solution as intramuscular injection administered over two periods

Outcomes

Primary Outcome Measures

AUC from 0 to 72 hours post-dose
Area under the curve
AUC
Area under the curve
Cmax from 0 to 72 hours post-dose
Maximum concentration

Secondary Outcome Measures

Adverse Events from Day 1 to Day 45
Adverse events
Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection
Area under the curve (AUC0-t)
Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection
Area under the curve (AUC0-inf)

Full Information

First Posted
August 31, 2022
Last Updated
January 20, 2023
Sponsor
Acasti Pharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05531890
Brief Title
Comparative Bioavailability of Betamethasone Oral Solution Metered Spray (GTX-102) in Healthy Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
November 24, 2022 (Actual)
Study Completion Date
May 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acasti Pharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ataxia Telangiectasia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2
Arm Type
Experimental
Arm Description
GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered fast or slow over two periods
Arm Title
Group 2a GTX-102 high dose fast in Period 1 and Period 2
Arm Type
Experimental
Arm Description
GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods Note: Note under US IND
Arm Title
Group 2b Oral comparator in Period 1 and Period 2
Arm Type
Active Comparator
Arm Description
0.1 mg/kg betamethasone solution oral drops solution over two periods Note: Not under US IND
Arm Title
Group 3 GTX-102 high dose fast or low dose fast in Period 1 and Period 2
Arm Type
Experimental
Arm Description
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
Arm Title
Group 4a GTX-102 high dose fast in Period 1 and Period 2
Arm Type
Experimental
Arm Description
GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods
Arm Title
Group 4b betamethasone intramuscular in Period 1 and Period 2
Arm Type
Active Comparator
Arm Description
0.1 mg/kg betamethasone solution as intramuscular injection administered over two periods
Intervention Type
Drug
Intervention Name(s)
GTX-102 medium dose fast Period 1 and Period 2
Intervention Description
GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered in Period 1 and Period 2 fast
Intervention Type
Drug
Intervention Name(s)
GTX-102 medium dose slow Period 1 and Period 2
Intervention Description
GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered in Period 1 and Period 2 slow
Intervention Type
Drug
Intervention Name(s)
GTX-102 high dose fast Period 1 and Period 2
Intervention Description
GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered in Period 1 and Period 2 fast
Intervention Type
Drug
Intervention Name(s)
GTX-102 low dose fast Period 1 and Period 2
Intervention Description
GTX-102 Betamethasone oral spray high dose (0.025 mg/kg) administered in Period 1 and Period 2 fast
Intervention Type
Drug
Intervention Name(s)
Betamethasone solution as intramuscular injection Period 1 and Period 2
Intervention Description
reference product 0.1 mg/kg betamethasone solution as an intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Betamethasone Oral Solution Period 1 and Period 2
Intervention Description
Comparator product 0.1 mg/kg betamethasone oral drops solution
Primary Outcome Measure Information:
Title
AUC from 0 to 72 hours post-dose
Description
Area under the curve
Time Frame
Up to 72 hours post-dose
Title
AUC
Description
Area under the curve
Time Frame
Up to infinity
Title
Cmax from 0 to 72 hours post-dose
Description
Maximum concentration
Time Frame
Up to 72 hours post-dose
Secondary Outcome Measure Information:
Title
Adverse Events from Day 1 to Day 45
Description
Adverse events
Time Frame
Day 1 to Day 45
Title
Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection
Description
Area under the curve (AUC0-t)
Time Frame
Up to 72 hours post-dose
Title
Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection
Description
Area under the curve (AUC0-inf)
Time Frame
Up to infinity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Faulknor, MD
Organizational Affiliation
Clinical Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Unit
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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