NL-OMON51024已完成不适用
A randomised, double-blind, placebo-controlled crossover study to investigate the effect of buprenorphine on fentanyl induced effects on nociceptive thresholds and CNS functioning in opioid tolerant patients. - Fentanyl Blockade Study in OT patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
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 ICF and able to comply with the requirements and restrictions
- •listed therein;
- •2. Male and female, 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 pregnancy test prior to enrolment 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. Opioid-tolerant patients administered opioids at daily doses >= 60 mg oral
- •morphine equivalents (See Appendix A);
- •6. Stable as defined by the Investigator, based on a medical evaluation that
- •includes the patient*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
- •1. Clinically significant risk factors of Torsades de Pointes (e.g., heart
- •failure, hypokalaemia, family history of Long QT Syndrome) or an ECG
- •demonstrating a Fridericia*s corrected QT interval (QTcF) > 450 msec in males
- •and QTcF > 470 msec in females at screening;
- •2. 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;
- •3. 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);
- •4. Not able to abstain from smoking cigarettes during each dose administration
- •5. 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);
- •6. Use of buprenorphine 10 days prior to the first study drug administration;
- •7. Use of prescription or OTC medications that are clinically relevant CYP P450
- •3A4 or CYP P450 2D6 inducers or inhibitors from 14 days prior to study drug
- •administration;
- •8. History of suicidal ideation within 30 days prior to informed consent or
- •history of a suicide attempt in the 6 months prior to informed consent;
- •9. Measured systolic blood pressure greater than 160 or less than 95 mmHg or
- •diastolic pressure greater than 95 mmHg prior to Day 1;
- •10. History or presence of allergic response to buprenorphine or fentanyl;
- •11. Opioid-tolerant patients who have demonstrated allergic reactions (e.g.,
- •food, drug, atopic reactions or asthmatic episodes) which, in the opinion of
- •the Investigator and sponsor, interfere with their ability to participate in
- •12. Estimated glomerular filtration rate <60 mL/min as estimated by the CKD-EPI
- •13. Clinical significant anaemia at screening or donation of > 250 mL of blood
- •or plasma within the last 3 months;
- •14. Positive serology tests for HIV, acute hepatitis B, or acute hepatitis C
- •(OT patients with asymptomatic hepatitis B or C infection may be enrolled);
- •15. AST or ALT levels >3.0 times the upper limit of normal at screening;
- •16. Any current, clinically significant, known medical condition in particular
- •any existing conditions that would affect sensitivity to cold (such as
- •atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism);
- •17. Treatment with another investigational drug within 3 months prior to dosing
- •or having participated in more than 4 investigational drug studies within 1
- •year prior to screening;
- •18. Site staff or subjects affiliated with, or a family member of, site staff
- •directly involved in the study.
研究者
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