NCT05517486

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Grace Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postherpetic Neuralgia

Interventions

Type	Name	Description
DRUG	GTX-101	Bupivacaine HCl metered spray
DRUG	Bupivacaine HCl subcutaneous injection	Bupivacaine HCl, 50 mg/10 mL

Timeline

• Start date: 2022-07-26
• Primary completion: 2022-08-21
• Completion: 2023-05-03
• First posted: 2022-08-26
• Last updated: 2023-01-23

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study