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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05517486
Other study ID # GTX-101-004
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date July 26, 2022
Est. completion date May 3, 2023

Study information

Verified date June 2022
Source Acasti Pharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 48
Est. completion date May 3, 2023
Est. primary completion date August 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GTX-101
Bupivacaine HCl metered spray
Bupivacaine HCl subcutaneous injection
Bupivacaine HCl, 50 mg/10 mL

Locations

Country Name City State
Canada Clinical Research Unit Montréal

Sponsors (1)

Lead Sponsor Collaborator
Acasti Pharma Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax between 0 hour to 240 hour after study drug administration Maximum concentration occuring at Tmax From 0 hour to 240 hour after study drug administration
Primary Tmax between 0 hour to 240 hour after study drug administration Time of maximum observed concentration From 0 hour to 240 hour after study drug administration
Primary AUC last Area under the concentration time curve from the time of last dosing to the time of last quantifiable concentration (Tlast) From 0 hour to 240 hour after study drug administration
Primary AUC inf Area under the concentration time curve extrapolated to infinity From 0 hour to 240 hour after study drug administration
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