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Single-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
Acasti Pharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia

Eligibility Criteria

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

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

First Posted
July 14, 2022
Last Updated
January 20, 2023
Sponsor
Acasti Pharma Inc.
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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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