Pharmacokinetics, Relative Bioavailability and Safety of INL-001 Compared to Marcaine After Open Hernioplasty
Condition: Hernioplasty
Intervention: INL-001 (bupivacaine HCl collagen implant); Marcaine 0.25% infiltration
Intervention description: 3 x 100 mg INL-001 bupivacaine HCl collagen-matrix implants (total bupivacaine HCl dose 300 mg); Marcaine 0.25% (bupivacaine HCl) 175 mg infiltration
Intervention MeSH terms: Bupivacaine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: This is a single-blind study in which the study subject is blinded to treatment group. All precautions will be taken to ensure that the blinding of the treatment group is maintained throughout the study period. Unblinding to the subject will not be permitted unless it is deemed necessary for appropriate treatment of a medical emergency.
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pharmacokinetics; Bioavailability; Safety; Bupivacaine; Collagen; Implant; Marcaine; Hernioplasty

Summary:

      This is a multicenter randomized, single-blind, controlled study. The primary objectives of
      this study are to obtain the pharmacokinetic profile and the relative bioavailability of the
      INL-001 matrix during and after open hernioplasty compared to Marcaine™ 0.25% infiltration.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for inclusion into the study, subjects must:

          -  Be a man or woman ≥18 years of age.

          -  Be eligible for unilateral inguinal hernioplasty with mesh (open laparotomy,
             tension-free technique) performed according to standard surgical technique under
             general anesthesia. Repair of multiple hernias through a single incision is permitted.
             If female of childbearing potential, have a negative pregnancy test at screening and
             before randomization on Day 1 AND be using an effective contraception method (ie,
             abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives,
             or barrier control) for at least one menstrual cycle prior to study enrollment and for
             the duration of the study, OR be surgically sterile, OR be a postmenopausal female (no
             menses for at least 1 year or hysterectomy).

          -  Has the ability and willingness to comply with the study procedures.

          -  Be willing to use only permitted medications throughout the study.

          -  Be willing to use opioid analgesia.

          -  Be able to fluently speak and understand either English or Spanish and be able to
             provide meaningful written informed consent for the study.

        Exclusion Criteria:

        A subject will be excluded from study participation if prior to surgery he/she:

          -  Has a known hypersensitivity to amide local anesthetics, morphine, acetaminophen, or
             bovine products.

          -  Is scheduled for bilateral inguinal hernioplasty or other significant concomitant
             surgical procedure.

          -  Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to
             undergo another laparotomy procedure within the 30 day postoperative period.

          -  Has known or suspected history of alcohol or drug abuse or misuse within 3 years of
             screening or evidence of tolerance or physical dependency on opioid analgesics or
             sedative-hypnotic medications.

          -  Has any clinically significant unstable cardiac, neurological, immunological, renal,
             hepatic or hematological 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.

          -  Has venous access difficulties that may preclude the frequent pharmacokinetic sampling
             requirements of the study.

          -  Has participated in a clinical trial (investigational or marketed product) within 30
             days of surgery.