A study examining the pharmacodynamic interaction between buprenorphine and fentanyl

Completed

• Conditions: Opioid Use Disorder; Respiratory depression; 10038716

• Registration Number: NL-OMON46809
• Lead Sponsor: Indivior UK Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2019-09-09
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

Part A:
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.
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 unless assessed as safe by the principal
investigator.

Exclusion Criteria

Part A:
- 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;
- 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);
- Not able to abstain from smoking cigarettes during each dose administration day;
- 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);
- Use of buprenorphine within 10 days of the first study drug administration;
- History or presence of allergic response to buprenorphine or fentanyl;

Study & Design

• Study Type: Interventional
• Study Design: Not specified