NCT04826328

Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Efficacy, and Systemic Exposure of a Single Administration of FX301 Via Nerve Block for Management of Post-surgical Pain Following Bunionectomy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy. Part I - three-step, single ascending dose study design in which two drug loads (low drug load of funapide and high drug load of funapide) and two volumes (high volume and low volume) of FX301 will be explored against placebo in four cohorts of 12 patients each (9 active:3 placebo) for the management of post-surgical pain in patients undergoing bunionectomy. Part II - expansion cohort to further assess safety, tolerability, systemic exposure, and efficacy of a selected drug load/volume of FX301. An additional 36 patients will be randomized in a 1:1 ratio to receive either FX301 or placebo as a single-injection analgesic nerve block adjacent to the sciatic nerve of the popliteal fossa.

Detailed description

This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy. Part I - three-step, single ascending dose study design in which two drug loads (low drug load of funapide and high drug load of funapide) and two volumes (high volume and low volume) of FX301 will be explored against placebo in four cohorts of 12 patients each (9 active:3 placebo) for the management of post-surgical pain in patients undergoing bunionectomy. At each step, the amount of FX301 administered (dose level) will be constant (65 mg, 130 mg, and 260 mg) so that the local safety of the drug loads and the volumes administered can be assessed separately. The 130 mg dose step will consist of both the low drug load at high volume and the high drug load at low volume concentrations. A Safety Monitoring Committee (SMC) will review all safety data of each dose step prior to escalation to the next dose level. After completion of the last cohort, data will be reviewed to assess whether to expand one of the four dose/volume cohorts up to and including the highest tolerated drug load/volume. Part II - expansion cohort to further assess safety, tolerability, systemic exposure, and efficacy of a selected drug load/volume of FX301. An additional 36 patients will be randomized in a 1:1 ratio to receive either FX301 or placebo as a single-injection analgesic nerve block adjacent to the sciatic nerve of the popliteal fossa.

Conditions

• Pain, Postoperative
• Bunion

Interventions

Type	Name	Description
DRUG	FX301	FX301 is an extended-release formulation of funapide being developed as a single injection peripheral nerve block for the management of acute postsurgical pain
DRUG	Normal Saline	Single peripheral nerve injection

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-01-11
• Completion: 2022-03-30
• First posted: 2021-04-01
• Last updated: 2022-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study