Phase II Pharmacokinetics Study of CAM2038
Condition: Opioid Use Disorder; Chronic Pain
MeSH terms: Chronic Pain; Opioid-Related Disorders
Intervention: CAM2038
Intervention description: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
Intervention MeSH terms: Buprenorphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Phase II, open label, partially randomized, three treatment group study designed to evaluate
      the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated
      subcutaneous administrations of CAM2038.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must provide written informed consent prior to the conduct of any study
             related procedures.

          2. Male or non pregnant, non lactating female subject, aged 19 to 65 years, inclusive.

          3. Body mass index between 19 and 35 kg/m2, inclusive.

          4. Current diagnosis of moderate to severe opioid use disorder (according to the DSM 5)
             or past medical history of opioid use disorder currently being treated with SL BPN.

          5. Subject must be taking SL BPN (Subutex® equivalent) 24 mg (Group 1 and Group 2) or ≥24
             mg (Group 3) daily for at least 30 days prior to Screening.

          6. Subject has a history of moderate to severe chronic non cancer pain.

          7. Male and female subjects of childbearing potential must be willing to use a reliable
             method of contraception during the entire study (Screening visit to Follow-up phone
             call).

          8. Subject must be willing and able to comply with all study procedures and requirements.

        Exclusion Criteria:

          1. Individuals meeting DSM-V substance use disorder criteria for alcohol,
             benzodiazepines, central nervous system (CNS) stimulants, or other drugs of abuse
             (excluding caffeine, tobacco or THC/marijuana).

          2. Any clinically significant abnormality on the basis of medical history, vital signs,
             physical examination, 12-lead electrocardiogram (ECG; Fridericia's corrected QT
             interval [QTcF] ≥450 msec. for males or ≥470 msec. for females), and laboratory
             evaluations (including hematology, clinical chemistry, urinalysis at Screening), in
             the opinion of the Investigator.

          3. Significant symptoms, medical conditions, or other circumstances which, in the opinion
             of the Investigator, would preclude compliance with the protocol, adequate cooperation
             in the study or obtaining informed consent, or may prevent the subject from safely
             participating in study, including subjects who are at a risk for gastrointestinal
             obstruction or paralytic ileus or who have severe respiratory insufficiency,
             respiratory depression, airway obstruction, gastrointestinal motility disorders,
             biliary tract disease, severe hepatic insufficiency, planned surgery and prior
             treatment with monoamine oxidase inhibitors.

          4. Use (therapeutic or non-therapeutic) of opioids other than SL BPN.

          5. Aspartate aminotransferase (AST) levels > 3 X the upper limit of normal, alanine
             aminotransferase (ALT), levels > 3 X the upper limit of normal, total bilirubin > 1.5
             X the upper limit of normal, or creatinine > 1.5 X upper limit of normal on the
             Screening laboratory assessments, or other clinically significant laboratory
             abnormalities, which in the opinion of the Investigator may prevent the subject from
             safely participating in study.

          6. Pregnant or lactating or planning to become pregnant during the study.

          7. Diagnosis of, or currently under investigation for, fibromyalgia, complex regional
             pain syndrome, neurogenic claudication due to spinal stenosis, spinal cord
             compression, acute nerve root compression, severe or progressive lower extremity
             weakness or numbness.

          8. History of chemotherapy or confirmed malignancy (except basal cell or squamous
             carcinoma of the skin) within the past 2 years.

          9. Clinically significant history of, or current evidence for, suicidal ideation or those
             who are actively suicidal, as based on the Columbia-Suicide Severity Rating Scale
             (C-SSRS; grade 4 or 5).

         10. Clinically significant history of major depressive disorder that is poorly controlled
             with medication.

         11. Hypersensitivity or allergy to BPN or other opioids, or excipients of CAM2038.

         12. Exposure to any investigational drug within the 4 weeks prior to Screening.

         13. Participants with a clinically significant history of risk factors of Torsades de
             Pointes and any existing ventricular tachyarrhythmias such as bigeminy, trigeminy,
             heart failure, hypokalemia, family history of Long QT Syndrome.

         14. On medications that have the potential for prolonging the QT interval or who may
             require such medications during the course of the study along with clinically
             significant abnormalities on screening electrocardiogram (ECG) readings as deemed by
             the investigator.

         15. Requires current use of agents that are strong inhibitors or inducers of cytochrome
             P450 3A4 (CYP3A4) such as some azole antifungals (e.g., ketoconazole), macrolide
             antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir,
             indinavir, and saquinavir).

         16. Intolerance to venipuncture and/or difficulty with venous access, as per the judgment
             of the Investigator/research staff.

         17. Is an employee of the Investigator or the study site, with direct involvement in the
             proposed study or other studies under the direction of the Investigator or study site,
             or is a family member of an employee or of the Investigator.

         18. Any pending legal action that could prohibit participation or compliance in the study.