Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder

Exclusion Criteria

• •Participants are excluded from the study if any of the following criteria apply:
• •1. Have a current diagnosis, other than OUD, requiring chronic opioid treatment.
• •2. Have a concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis or alcohol use disorders.
• •3. Meet DSM-5 criteria for severe substance use disorder other than opioids.
• •4. Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder that would impact participation in the study as judged by an Investigator or medically responsible physician.
• •5. Had an opioid overdose event within the 6 months prior to the Screening Visit.
• •6. Uses any substance of abuse via the injection route more than 2 times per week over the last 3 months prior to Screening.
• •7. Have clinically significant abnormal biochemistry, hematology or urinalysis results that would impact participation in the study as judged by an Investigator or medically responsible physician.
• •8. Have a history of narcolepsy, cataplexy, obstructive or central sleep apnea.
• •9. Have disorders that may interfere with drug absorption, distribution, metabolism and excretion processes.
• •10. History of suicidal ideation within 30 days prior to providing written informed consent as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at the Screening Visit or history of a suicide attempt (per the C-SSRS) in the 6 months prior to informed consent.
• •11. Serious cardiac illness or other cardiac assessments including, but not limited to:
• •* Uncontrolled arrhythmias.
• •* History of congestive heart failure.
• •* Myocardial infarction \<6 months from receipt of first dose of investigational medicinal product (IMP)
• •* Uncontrolled symptomatic angina
• •* QT interval corrected with Fridericia's formula (QTcF) \>450 msec for males and \>470 msec for females or history of prolonged QT syndrome.
• •12. Have any combination of the following at screening:
• •* Total bilirubin ≥1.5×upper limit of normal (ULN) (with direct bilirubin \>1.3 mg/dL),
• •* Alanine aminotransferase (ALT) ≥3×ULN
• •* Aspartate aminotransferase (AST) ≥3×ULN
• •* International normalized ratio (INR) \>1.2 for participants not receiving anticoagulation therapy, \>3.0 for participants on conventional coagulation therapy, \>3.5 for participants on intensive anticoagulation, or
• •* Estimated glomerular filtration rate \<60 mL/min by Cockroft-Gault formula.
• •13. Current symptomatic hepatic or biliary disease, including participants with cholecystectomy \<90 days prior to Screening.
• •14. Use of a long-acting buprenorphine or naltrexone treatment for OUD within 2 years or 1 year of the screening visit, respectively.
• •15. Concurrent treatment or treatment with an investigational drug, or participation in any other clinical study within 30 days prior to the signing the informed consent form.
• •16. Blood or platelets donation of greater than 500 mL within 56 days or plasma donation within 7 days of screening; clinically significant anemia or low hemoglobin (\<11 g/dL for females, \<12 g/dL for males).
• •17. Known allergy or hypersensitivity to IMP or its excipients.
• •18. Any condition that, in the opinion of an Investigator or medically responsible physician, would interfere with evaluation of the IMP or interpretation of participant safety or study results.
• •19. Is a member of site staff, has a financial interest in Indivior, or is an immediate family member of anyone directly involved in the study (ie, site staff, Indivior, or Clinical Research Organization \[CRO\] employee).
• •20. Participants who are unable, in the opinion of an Investigator or medically responsible physician, to comply fully with the study requirements, including prohibited concomitant therapies.
• •21. Current incarceration, treatment for OUD required by court order, or pending incarceration/legal action that could prevent participation or compliance in the study.