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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Postherpetic Neuralgia

Intervention / Treatment
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* Drug: GTX-101
* Drug: Bupivacaine HCl subcutaneous injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 mg GTX-101<br> | Drug: GTX-101<br>* Bupivacaine HCl metered spray<br>* Other names: Bupivacaine HCl metered spray;|
| Experimental: 100 mg GTX-101<br> | Drug: GTX-101<br>* Bupivacaine HCl metered spray<br>* Other names: Bupivacaine HCl metered spray;|
| Experimental: 200 mg GTX-101<br> | Drug: GTX-101<br>* Bupivacaine HCl metered spray<br>* Other names: Bupivacaine HCl metered spray;|
| Active Comparator: Bupivacaine subcutaneous injection<br> | Drug: Bupivacaine HCl subcutaneous injection<br>* Bupivacaine HCl, 50 mg/10 mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| AUC inf | Area under the concentration time curve extrapolated to infinity | From 0 hour to 240 hour after study drug administration |