Single-dose to Evaluate the Pharmacokinetics of GTX-101 and Subcutaneous Injectable Bupivacaine in Healthy Subjects

Postherpetic Neuralgia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05517486
• Other study ID #: GTX-101-004
• Status: Active, not recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

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