Pharmacokinetic Study of Vivitrol in Healthy Participants
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Intervention: Naltrexone 380 MG
Intervention description: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
Intervention MeSH terms: Naltrexone
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 57 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: naltrexone; opioids; Opioid Use Disorder

Summary:

      This is a Phase I, single-center, single arm, open-label study, to establish the
      pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug
      Administration (FDA) approved medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed GM0017 (i.e. been administered OLANI (3.6 gram) and provided two
             consecutive monthly blood samples of NTX below 0.1 ng/mL)

          -  Men or women between ≥18 and <58 years old Without 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 an injection of NTX to allow for investigational drug
             administration in the intramuscular tissue

          -  Have an initial weight between 45.3 and 81.6 kilograms (inclusive) or have a BMI
             inclusive of 18.5 to 30.0.

        Exclusion Criteria:

          -  Is currently on active NTX medication.

          -  Positive UDS at screening for illicit substances.

          -  Has a condition which requires treatment with opioid based medication.

          -  Has a known hypersensitivity to NTX.

          -  Is prone to skin rashes, irritation or has a skin condition such as recurrent eczema
             that is likely to impact the injection site area, or as determined by the evaluating
             physician.

          -  Demonstrates any abnormal skin tissue in the proposed injection area.

          -  Is pregnant or planning to be. Women need to have negative pregnancy test at
             screening. Women need to agree to practice an effective method of contraception
             throughout participation.

          -  Participant is breastfeeding or planning to be.

          -  Has a current significant neurological (including cognitive and psychiatric
             disorders),

          -  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.

          -  ALT or 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 MINI 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, 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.

          -  Is allergic to any of the ingredients in Vivitrol or the diluent used to mix Vivitrol
             (i.e. carboxymethylcellulose sodium, polysorbate 20, sodium chloride, sodium hydroxide
             and hydrochloric acid as pH adjusters, in water for injection).