Back to resultsSingle-dose to Evaluate the Pharmacokinetics of GTX-101 and Subcutaneous Injectable Bupivacaine in Healthy Subjects
Primary Purpose
Postherpetic Neuralgia
Status
Active
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
GTX-101
Bupivacaine HCl subcutaneous injection
Sponsored by
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form (ICF)
- Healthy adult male or female, aged 18 to 55 years, inclusive, at Screening
- Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m2, inclusively at Screening
- Have no clinically significant diseases captured in the medical/surgical history or evidence of clinically significant findings on the physical examination (including vital signs), weight and/or clinical laboratory tests and/or ECG, as determined by an Investigator
Exclusion Criteria:
- History of significant hypersensitivity to bupivacaine, local anesthetic agents of amide type, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
Sites / Locations
- Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
50 mg GTX-101
100 mg GTX-101
200 mg GTX-101
Bupivacaine subcutaneous injection
Arm Description
Outcomes
Primary Outcome Measures
Cmax between 0 hour to 240 hour after study drug administration
Maximum concentration occuring at Tmax
Tmax between 0 hour to 240 hour after study drug administration
Time of maximum observed concentration
AUC last
Area under the concentration time curve from the time of last dosing to the time of last quantifiable concentration (Tlast)
AUC inf
Area under the concentration time curve extrapolated to infinity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05517486
Brief Title
Single-dose to Evaluate the Pharmacokinetics of GTX-101 and Subcutaneous Injectable Bupivacaine in Healthy Subjects
Official Title
Parallel Study to Evaluate the Pharmacokinetics, Dose Proportionality, Safety and Tolerability of GTX-101 (Bupivacaine Hydrochloride Metered Dose Spray) and Subcutaneous Injectable Bupivacaine in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 26, 2022 (Actual)
Primary Completion Date
August 21, 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
This is a single-center, randomized, single-dose, active-controlled study in healthy male and female subjects.
The study will enroll subjects to evaluate the PK of 3 dose strengths (50 mg, 100 mg and 200 mg) of GTX-101 compared to Subcutaneous injection in healthy adult subjects.
Blood samples for PK assessments will be collect at specified time points. Safety assessments will also be performed throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
50 mg GTX-101
Arm Type
Experimental
Arm Title
100 mg GTX-101
Arm Type
Experimental
Arm Title
200 mg GTX-101
Arm Type
Experimental
Arm Title
Bupivacaine subcutaneous injection
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
GTX-101
Other Intervention Name(s)
Bupivacaine HCl metered spray
Intervention Description
Bupivacaine HCl metered spray
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCl subcutaneous injection
Intervention Description
Bupivacaine HCl, 50 mg/10 mL
Primary Outcome Measure Information:
Title
Cmax between 0 hour to 240 hour after study drug administration
Description
Maximum concentration occuring at Tmax
Time Frame
From 0 hour to 240 hour after study drug administration
Title
Tmax between 0 hour to 240 hour after study drug administration
Description
Time of maximum observed concentration
Time Frame
From 0 hour to 240 hour after study drug administration
Title
AUC last
Description
Area under the concentration time curve from the time of last dosing to the time of last quantifiable concentration (Tlast)
Time Frame
From 0 hour to 240 hour after study drug administration
Title
AUC inf
Description
Area under the concentration time curve extrapolated to infinity
Time Frame
From 0 hour to 240 hour after study drug administration
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:
Provision of signed and dated informed consent form (ICF)
Healthy adult male or female, aged 18 to 55 years, inclusive, at Screening
Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m2, inclusively at Screening
Have no clinically significant diseases captured in the medical/surgical history or evidence of clinically significant findings on the physical examination (including vital signs), weight and/or clinical laboratory tests and/or ECG, as determined by an Investigator
Exclusion Criteria:
History of significant hypersensitivity to bupivacaine, local anesthetic agents of amide type, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Sicard, MD
Organizational Affiliation
Clinical Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Unit
City
Montréal
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Single-dose to Evaluate the Pharmacokinetics of GTX-101 and Subcutaneous Injectable Bupivacaine in Healthy Subjects
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