NL-OMON46809
Completed
N/A
A study examining the pharmacodynamic interaction between buprenorphine and fentanyl - Buprenorphine-Fentanyl Interaction Study
Indivior UK Ltd.0 sites22 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Indivior UK Ltd.
- Enrollment
- 22
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed the informed consent form (ICF) and able to comply with the study requirements and restrictions listed therein;
- •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), haematology, 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.
Exclusion Criteria
- •\- 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;
- •\- 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);
- •\- Current smokers and those who have smoked within the last 6 months;
- •\- Current users of e\-cigarettes and nicotine replacement products and those who have used these products within the last 6 months;
- •\- 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);
- •\- 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;
- •\- Previous or current treatment with opioid agonist, partial agonist, or antagonist treatment within 30 days prior to the first study drug administration;
- •\- 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]);
- •\- History or presence of allergic response to buprenorphine or fentanyl;;Part B:
- •\- 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;
Outcomes
Primary Outcomes
Not specified
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