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Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT04826328•Pacira Pharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written consent to participate in the study
•2. Be willing and able to complete study procedures and pain scales, follow instructions and communicate meaningfully in English with study personnel, and return for outpatient follow-up visits as required.
•3. Male or female ≥18 to ≤65 years of age, inclusive
•4. Planning to undergo an elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation, without collateral procedure or additional surgeries, to be performed under Monitored Anesthesia Care (MAC) and be eligible to receive a popliteal sciatic nerve block
•5. Classified as either ASA 1 or ASA 2 by the American Society of Anesthesiologists Physical Status Classification System (Appendix 1).
•6. Has a BMI of ≥18 to ≤ 35 kg/m2.
•7. Willing to washout from all prohibited medications for the longer of 14 days or five half-lives prior to dosing, and abstain from those medications through the end of study (Appendix 5).
•8. If a male, unless he has a same sex partner, be either sterile (surgically or biologically) or commit to an acceptable method of birth control while participating in the study.
•9. If a woman of childbearing potential (WOCBP), must meet all of the following:
•* Not be pregnant (WOCBP must have a negative serum pregnancy test at screening and negative urine pregnancy test before surgery);
+5 more criteria

Exclusion Criteria

•1. Has a concurrent painful condition, other than bunion-related pain, that may require analgesic treatment during the study period or may confound post-surgical pain assessments.
•2. Has an active skin disease or other clinically significant abnormality at the anticipated site of surgery or nerve block insertion site that could interfere with the planned surgery.
•3. Has had previous bunionectomy or other surgical procedure on the index foot that could impact the current bunion surgery.
•4. Has any clinically significant cardiac, respiratory, neurological, immunological, hematological, or renal disease or any other condition that, in the opinion of the investigator, could compromise the subject's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
•5. Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any NSAIDs; history of NSAID-induced bronchospasm (subjects with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully); or hypersensitivity, allergy, or significant reaction to any other drugs used in the study, including anesthetics and antibiotics that may be required on the day of surgery.
•6. Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
•7. Has taken any opioids, NSAIDS, or acetaminophen within 3 days prior to the scheduled surgery. Low dose aspirin (\<100 mg) for cardiovascular protection is acceptable.
•8. Has initiated treatment with any of the following medications within 30 days prior to study medication administration or is taking any of these medications to control pain: selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, gabapentin, pregabalin, or cyclooxygenase-2 inhibitors. (Note: If a subject is taking one of these medications for a reason other than pain control, the subject must be on a stable scheduled dose \[i.e., not "as needed"\] for at least 1 month prior to study medication administration.)
•9. Within the 14 days prior to surgery, be taking parenteral or oral corticosteroids (steroid inhalers for allergy or asthma treatment, topical steroids for a non-clinically significant skin condition not involving the area of surgery, or ophthalmic steroids are permissible).
•10. Is currently receiving antianginal therapy
+13 more criteria

Locations (1)

Lotus Clinical Research, Huntington Hospital

Pasadena, California, United States

Key Dates

Start Date

March 15, 2021

Primary Completion Date

January 11, 2022

Completion Date

March 30, 2022

Last Updated

August 26, 2022

Enrollment

ACTUAL participants

Conditions

Pain, PostoperativeBunion

Interventions

FX301

DRUG

Normal Saline

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 26, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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