Phase II Pharmacokinetics Study of CAM2038
Phase II Pharmacokinetics Study of CAM2038
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.
This is a 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 weekly and monthly at different injection
 sites and to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine
 after repeated subcutaneous administration of CAM2038 monthly in opioid dependent subjects
 with a history of chronic non cancer pain. The study will involve three phases: Screening,
 Treatment, and Follow up.
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.