The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Intervention: naltrexone implant
Intervention description: 1.8 g implant containing 60% naltrexone
Intervention MeSH terms: Naltrexone
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: naltrexone; opioids; opioid use disorder; OLANI implant

Summary:

      This study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting
      Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated
      in an open label manner. No randomization will occur. It is hypothesized that the OLANI will
      provide sustained therapeutic doses of naltrexone (NTX) for periods up to 6 months via a
      single subcutaneous application of 2 OLANIs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women between the ages of 18 and 55 years old (inclusive)

          -  Without The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM
             5) - Substance Related Disorders classification; in sustained remission is not
             exclusionary

          -  Able and willing to comply with the requirements of the protocol

          -  Able and willing to provide written informed consent

          -  Willing to undergo a minor surgical procedure under local anesthetic to allow for
             investigational drug administration in the subcutaneous tissue

          -  BMI inclusive of 18.5 to 30.0

          -  Have an initial weight between 45.3 and 81.6 kilograms (inclusive)

        Exclusion Criteria:

          -  Positive urine drug screen (UDS) at screening for illicit substances.

          -  Is currently on naltrexone medication.

          -  Has had a naltrexone implant in the past 24 months.

          -  Has received treatment with an extended naltrexone product (e.g. Vivitrol) in the past
             12 months.

          -  Has a condition which requires treatment with opioid based medication.

          -  Has a known hypersensitivity to naltrexone.

          -  Has a known hypersensitivity to poly-lactic based materials e.g. biodegradable
             sutures, surgical implants or previous biodegradable implants.

          -  Has a known hypersensitivity to local anesthesia.

          -  Is prone to skin rashes, irritation or has a skin condition such as recurrent eczema
             that is likely to impact the implant site area, or as determined by the evaluating
             physician.

          -  Demonstrates any abnormal skin tissue in the proposed implantation area.

          -  Is pregnant or planning to be. Women need to have negative blood pregnancy test at
             screening. Women need to agree to practice dual contraceptives.

          -  Participant is breastfeeding or planning to be.

          -  Has a current significant neurological (including cognitive and psychiatric
             disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary,
             hematological or metabolic disease unless currently controlled and stable with
             protocol-allowed medication 30 days prior to proposed investigational product
             administration.

          -  Any clinically important abnormal finding as determined by medical history, physical
             examination, ECG or clinical laboratory tests.

          -  Any additional condition(s) that in the investigator's opinion would prohibit the
             participant from completing the study or would not be in the best interest of the
             participant.

          -  Alanine aminotransferase (ALT) or aspartate transaminase (AST) > 3 times the upper end
             of the laboratory normal range.

          -  Any methadone use 14 days prior to screening, and up to Study Day 0.

          -  Current DSM-5 diagnosis of schizophrenia, bipolar, anxiety, or depressive disorder,
             confirmed by The Mini International Neuropsychiatric Interview (MINI) diagnostic
             interview assessment, or currently treated with medications for anxiety or depression.
             Past history (in remission DSM-5 classification) of anxiety or depression is not
             exclusionary.

          -  Any elevated risk for suicide measured using the Columbia Suicide Severity Rating
             Scale (C-SSRS), endorsing any of the items in the past month (C-SSRS, Lifetime)

          -  Is participating or intending to participate in any other clinical trial during the
             duration of this study.