Study in Subjects Undergoing Complete Abdominoplasty
Condition: Postsurgical Pain
MeSH terms: Pain, Postoperative
Intervention: CA-008 5 mg; Placebo; Bupivacaine Hydrochloride; Hydromorphone; Fentanyl; Acetaminophen; Oxycodone; CA-008 10 mg; CA-008 15 mg
Intervention description: 5 mg CA-008 reconstituted in saline.; Each cohort will use placebo reconstituted in saline.; 0.25% administered pre-surgery; 0.02 mg/kg IV administered intraoperatively; 100 mcg IV administered intraoperatively; 1000 mg IV administered intraoperatively; 5-10 mg PO administered post-surgery; 10 mg CA-008 reconstituted in saline.; 15 mg CA-008 reconstituted in saline.
Intervention MeSH terms: Acetaminophen; Fentanyl; Oxycodone; Hydromorphone; Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Phase 2, single center, randomized, double-blind, placebo-controlled, parallel design study
      of CA-008 vs. placebo in subjects undergoing an elective C-ABD under general anesthesia
      supplemented with a bupivacaine hydrochloride (HCl)transverse abdominis plane (TAP) block.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Plan to undergo an elective complete abdominoplasty (C-ABD), without collateral
             procedure or additional surgeries.

          -  In the medical judgment of the investigator, be a reasonably healthy adult aged 18 -
             65 years old, inclusive, and American Society of Anesthesiology (ASA) physical Class 1
             or 2 at the time of randomization.

          -  Unless the subject has a same sex partner, he or she must either be sterile
             (surgically or biologically) or commit to an acceptable method of birth control while
             participating in the study.

          -  Have a body mass index ≤ 35 kg/m².

          -  Be willing and able to sign the informed consent form (ICF) approved by an
             Institutional Review Board (IRB).

        Key Exclusion Criteria:

          -  In the opinion of the Investigator, have a concurrent painful condition that may
             require analgesic treatment during the study period or may confound post-surgical pain
             assessments.

          -  Have a known allergy to chili peppers, capsaicin or the components of CA-008,
             acetaminophen, bupivacaine, fentanyl hydromorphone or oxycodone.

          -  As determined by the investigator have a history or clinical manifestation of
             significant medical, neuropsychiatric or other condition, including a clinically
             significant existing arrhythmia, left bundle branch block or abnormal ECG, myocardial
             infarction or coronary arterial bypass graft surgery within the prior 12 months,
             significant abnormal clinical laboratory test value, or known bleeding abnormality
             that could preclude or impair study participation or interfere with study assessments.

          -  The following are considered disallowed medications:

               1. Be tolerant to opioids defined as those who have been receiving or have received
                  chronic opioid therapy greater than 15 mg of oral morphine equivalents per day
                  for greater than 3 out of 7 days per week over a one-month period within 6 months
                  of screening.

               2. Within 1 day prior to surgery and throughout the inpatient period, be taking any
                  capsaicin-containing products, such as dietary supplements or over-the-counter
                  (OTC) preparations, including topical formulations, and prescription medications.

               3. Within the 7 days prior to surgery, be taking any central nervous system (CNS)
                  active agent as an analgesic adjunct medication, such as anticonvulsants,
                  antidepressants, benzodiazepines, sedative- hypnotics, clonidine and other
                  central alpha-2 agents, ketamine or muscle relaxants.

             i. These drugs are permitted if prescribed for non-pain indications and the dose has
             been stable for at least 30 days prior to surgery.

        ii. The use of benzodiazepines and the non-benzodiazepines are permitted to treat insomnia
        during the postoperative period.