A study examining the interaction between buprenorphine and fentanyl

Part A:

1. Signed the informed consent form (ICF) and able to comply with the study requirements and restrictions listed there in;

2. Male and female subjects, age 18 to 45 years, inclusive;

3. Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 3 months after the last dose of study drug;

4. Body Mass Index (BMI) 18 to 30 kg/m2, inclusive

5. Healthy as defined by the Investigator, based on a medical evaluation that includes the subject’s medical and surgical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, and urinalysis;

6. No history of substance use disorder;

7. No current use of any central nervous system (CNS) depressants prescribed or otherwise.



Part B:

1. Signed the ICF and able to comply with the requirements and restrictions listed therein;

2. Males or females age 18 to 55 years, inclusive;

3. Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 3 months after the last dose of study drug.

4. BMI 18 to 32 kg/m2, inclusive;

5. Patients administered prescription opioids or heroin obtained through a medical heroin dispensation program) at daily doses ≥ 90 mg

6. Stable as defined by the Investigator, based on a medical evaluation that includes the subject’s medical and surgical history, physical examination, vital signs, 12-lead ECG, haematology, blood chemistry, and urinalysis;

7. No current use of any CNS depressants, besides opioids, prescribed or otherwise for 5 half-lives of the product before first study drug administration.

Part A :

1. Currently meet the criteria for diagnosis of substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria on any substance;

2. Any other active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;(including sleep apnoea, other significant respiratory illness, history or risk of difficult intubation, limited cervical spine mobility or limited oral excursion);

3. Current smokers and those who have smoked within the last 6 months;

4. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months;

5. Consume, on average, >20 units/week of alcohol in men and >13 units/week of alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass of wine or 25 mL of 40% spirit);

6. Previous treatment with any prescribed medications (including all type of vaccines) or over-the-counter (OTC) medications (including homeopathic preparations, vitamins, and minerals) within 14 days or 5 half-lives (whichever is longer) prior to first study treatment administration;

7. Previous or current treatment with opioid agonist, partial agonist, or antagonist treatment within 30 days prior to the first study drug administration;

8. Require on-going prescription or OTC medications that are clinically relevant CYP P450 3A4 or CYP P450 2C8 inducers or inhibitors (e.g., rifampicin, azole antifungals [e.g., ketoconazole], macrolide antibiotics [e.g., erythromycin]);

9. History or presence of allergic response to buprenorphine or fentanyl;



Part B:

1. Currently meet the criteria for diagnosis of moderate or severe substance use disorder according to the DSM-5 criteria on any substances other than opioids, caffeine, or nicotine;

2. Any active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;including sleep apnoea, other significant respiratory illness, history or risk of difficult intubation, limited cervical spine mobility or limited oral excursion);

3. Smoking of >10 cigarettes/day or equivalent and not able to abstain from smoking cigarettes during each dose administration day;

4. Consume, on average, >27 units/week of alcohol in men and >20 units/week of alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass of wine or 25 mL of 40% spirit);

5. Use of buprenorphine within 10 days of the first study drug administration;

6. Currently receiving Medication-Assissted Therapy (MAT) for the treatment of Opioid Use Disorder (OUD);

7. History or presence of allergic response to buprenorphine or fentanyl;