A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity

NCT03307837 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CA-PS-2017-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hallux Valgus Deformity

Keywords

Unilateral Transpositional First Metatarsal Osteotomy

Outcome Measures

Primary Outcomes (2)

• Surgical Site Assessment

  Assessment of skin reactions to determine if any change from 24 to 48 hours.

  24 and 48 hours post infiltration

• Neurosensory Assessment

  Change in neurosensory assessments of the skin surrounding the incision.

  48 hours post infiltration

Secondary Outcomes (2)

• 11-point (0-10) Numerical Pain Rating Scale (NPRS)

  time 0 to Day 15

• Postoperative Use of Analgesics

  Daily up through Day 15

Study Arms (6)

CA-008 Cohort 1 0.5 mg

ACTIVE COMPARATOR

Intra-operative, local administration

Drug: CA-008

CA-008 Cohort 2 1 mg

ACTIVE COMPARATOR

Intra-operative, local administration

Drug: CA-008

CA-008 Cohort 3 2 mg

ACTIVE COMPARATOR

Intra-operative, local administration

Drug: CA-008

CA-008 Cohort 4 3 mg

ACTIVE COMPARATOR

Intra-operative, local administration

Drug: CA-008

CA-008 Cohort 5 4.2 mg

ACTIVE COMPARATOR

Intra-operative, local administration

Drug: CA-008

Placebo

PLACEBO COMPARATOR

Intra-operative, local administration of saline (equivalent volume in active comparator arm)

Drug: Placebo

Interventions

CA-008 DRUG

Local administration during surgery

CA-008 Cohort 1 0.5 mg; CA-008 Cohort 2 1 mg; CA-008 Cohort 3 2 mg; CA-008 Cohort 4 3 mg; CA-008 Cohort 5 4.2 mg

Placebo DRUG

Local administration during surgery

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 2.
• 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;
• Be surgically sterile; or at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or is practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study and for 30 days from completion of the study.
• Have a body mass index ≤ 35 kg/m2.
• Willing and able to sign the informed consent form (ICF) approved by the Institutional Review Board (IRB).
• Willing and able to complete the study procedures and pain scales, and to communicate meaningfully in English with study personnel.

You may not qualify if:

• 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-008.
• 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 1. 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.
• Have evidence of a clinically significant 12-lead ECG abnormality according to the judgment of the investigator, including QTcF \>450 for men and \>470 for women.
• Use of dietary supplements or over-the-counter (OTC) medications containing significant amounts of capsaicin within 1 day prior to Day 1, and throughout the hospitalization period.
• Subjects with active cutaneous disease, or other disease, at the anticipated site of surgery.
• History of peripheral vascular disease, sickle cell disease, vascular grafts, or vasospastic disorders.
• Use of parenteral or oral corticosteroid(s) within 14 days prior to Day 1.
• Known bleeding disorder or is taking agents affecting coagulation preoperatively. Deep venous thrombosis (DVT) prophylaxis of the surgeon's choice is permitted postoperatively.

Sponsors & Collaborators

• Concentric Analgesics: lead

Study Sites (1)

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

Results Point of Contact

• Title: Dr. John Donovan, President and Founder
• Organization: Concentric Analgesics

JOHN@CONCENTRICANALGESICS.COM

415-676-8940

Study Officials

• John Donovan, MD

  Concentric Analgesics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 12, 2017
• Study Start: November 2, 2017
• Primary Completion: March 20, 2018
• Study Completion: April 25, 2018
• Last Updated: June 30, 2021
• Results First Posted: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)