A Phase 1/Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of a Single Intraoperative Administration of CA-008 in Subjects Undergoing Correction of Hallux Valgus Deformity

Concentric Analgesics1 site in 1 country40 target enrollmentNovember 2, 2017

ConditionsHallux Valgus Deformity

InterventionsCA-008 Placebo

DrugsCA-008 Placebo

Overview

Phase: Phase 1
Intervention: CA-008
Conditions: Hallux Valgus Deformity
Sponsor: Concentric Analgesics
Enrollment: 40
Locations: 1
Primary Endpoint: Neurosensory Assessment
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Detailed Description

This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo. Placebo patients from each cohort were pooled for analysis. The initial cohort will receive the lowest planned dose of CA-008, and sequential cohorts will receive escalating doses of CA-008 in a fixed volume of administration. There will be at least a 6-day period between cohorts, in order to ensure a minimum of 3 days to review safety data from the last subject in a cohort and to allow the meeting of the Data Monitoring Committee (DMC) to review the safety data from the entire cohort prior to a making decision for dose escalation. Dose escalation rules will be protocol defined. Subjects will be undergoing unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus deformity (bunionectomy). In accordance with standard of care, subjects will receive regional anesthesia (MAYO block) with 0.5% bupivacaine. Prior to wound closure, 10 mL of study drug will be injected into the soft tissues and periosteum of the surgical site. After the surgery, subjects will be monitored for 48 hours at the trial site. Safety and efficacy evaluations will be performed as described herein. Subjects will be required to meet certain pre-specified criteria prior to discharge.

Registry

clinicaltrials.gov

Start Date

November 2, 2017

End Date

April 25, 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Concentric Analgesics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged 18 - 65 years old, inclusive.
•Planning to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures.
•Be American Society of Anesthesiology (ASA) physical Class 1 or
•In good health and capable of undergoing a bunionectomy under regional anesthesia.
•No additional planned surgeries other than a bunionectomy during the course of the study.
•Male subjects must be either sterile (surgically or biologically), or commit to an acceptable method of birth control while participating in the study.
•Female subjects are eligible only if all of the following apply:
•Not pregnant (female subject of child bearing potential must have a negative serum pregnancy tests at screening and negative urine pregnancy test before surgery);
•Not lactating;
•Not planning to become pregnant during the study;

Exclusion Criteria

•Subjects with a history of hypertension, cardiovascular disease and a history of cerebrovascular events.
•Subjects with concurrent painful conditions that may require analgesic treatment during the study period, or, in the opinion of the Investigator, may confound post-operative pain assessments.
•Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of study treatment initiation.
•Have a known allergy or intolerance to the following medications or related substances: capsaicin, chili peppers, propofol, bupivacaine, benzodiazepines, midazolam, oxycodone, or ondansetron.
•Have a clinically significant abnormal clinical laboratory test value according to the judgment of the investigator.
•Have, as determined by the investigator or the study's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
•Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which, in the investigator's opinion, may exert significant analgesic properties or act synergistically with CA-
•Use of disallowed pain medications within 2 days prior to Day 1 (NSAIDs, COX-2 inhibitors, tramadol, ketamine, clonidine, gabapentin, pregabalin, or cannabinoids).
•Use of central nervous system (CNS) active drugs such as benzodiazepines, tricyclic antidepressants, SNRIs, or SSRIs for pain within seven days prior to Day
•These drugs are permitted for non-pain indications if the dose has been stable for at least 30 days prior to Day 1 and is planned to remain stable throughout the study. The use of lorazepam and other sleep medications, except those containing analgesic properties, is permitted.