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

Phase 1

• Conditions: Postherpetic Neuralgia
• Interventions: Drug: Bupivacaine HCl subcutaneous injection; Drug: GTX-101

• Registration Number: NCT05517486
• Lead Sponsor: Acasti Pharma Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-07-14
• Study Start: 2022-07-26
• Primary Completion: 2022-08-21
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23
• Study Completion: 2023-05-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine subcutaneous injection	Bupivacaine HCl subcutaneous injection	-
200 mg GTX-101	GTX-101	-
100 mg GTX-101	GTX-101	-
50 mg GTX-101	GTX-101	-

Primary Outcome Measures

Name	Time	Method
AUC inf	From 0 hour to 240 hour after study drug administration	Area under the concentration time curve extrapolated to infinity
AUC last	From 0 hour to 240 hour after study drug administration	Area under the concentration time curve from the time of last dosing to the time of last quantifiable concentration (Tlast)
Cmax between 0 hour to 240 hour after study drug administration	From 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	From 0 hour to 240 hour after study drug administration	Time of maximum observed concentration

Trial Locations

Locations (1)

Clinical Research Unit; 🇨🇦 Montréal, Canada