Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy
Condition: Pain, Postoperative; Bunion
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): FX301; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): FX301 is an extended-release formulation of funapide being developed as a single injection peripheral nerve block for the management of acute postsurgical pain; Single peripheral nerve injection
Other intervention name(s): funapide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part I - Double-Blind, placebo-controlled, three-step, Single Ascending Dose Part II - Double Blind, placebo-controlled, Expansion Phase to enroll additional patients to an SMC-cleared dose/volume level
Masking: Double (Participant, Investigator)
Primary purpose: Treatment