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

Acasti Pharma

Status and phase: Active, not recruiting; Phase 1

Conditions: Postherpetic Neuralgia

Treatments: Drug: Bupivacaine HCl subcutaneous injection; Drug: GTX-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT05517486

GTX-101-004

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

50 mg GTX-101

Experimental group

Treatment:

Drug: GTX-101

100 mg GTX-101

Experimental group

Treatment:

Drug: GTX-101

200 mg GTX-101

Experimental group

Treatment:

Drug: GTX-101

Bupivacaine subcutaneous injection

Active Comparator group

Treatment:

Drug: Bupivacaine HCl subcutaneous injection