drugset / Trial / NCT05517486

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

NCT05517486

Phase 1 Unknown 48 enrolled Grace Therapeutics Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-07-26
Primary completion
2022-08-21
Completion
2023-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 50 mg Subcutaneous
Subject Bupivacaine Other / unclassified 100 mg Subcutaneous
Subject Bupivacaine Other / unclassified 200 mg Subcutaneous