NL-OMON46809已完成不适用
A study examining the pharmacodynamic interaction between buprenorphine and fentanyl - Buprenorphine-Fentanyl Interaction Study
Indivior UK Ltd.0 个研究点目标入组 22 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •- 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;
研究者
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