EUCTR2021-006334-39-NL进行中（未招募）1 期
Protocol title should be: A randomised, double-blind, placebo-controlled, dose-ranging partial-block crossover study to investigate the effect of intravenous oliceridine on CNS functioning and nociceptive thresholds in healthy subjects, compared to morphine.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Trevena Inc
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all the following criteria to be included in this study:
- •1.Signed informed consent prior to any study-mandated procedure.
- •2.Ability to communicate well with the Investigator in the Dutch language and willing and able to follow the procedures and comply with study restrictions as outlined in the protocol.
- •3.Healthy male and female volunteers aged =18 years and =55years old at the time of informed consent.
- •4.Body mass index (BMI) =18 and <32 kg/m2 at Screening.
- •5.Females of childbearing potential must agree to use condoms from screening through 5 half lives or 90 days, whichever is longer, after administration of the last dose of IP, and must be willing to use a highly effective method of contraception (e.g. intrauterine device (IUD), diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or a tubal ligation) from screening through 5 half-lives or 90 days after administration of the last dose of IP.
- •6.Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms from screening through 5 half-lives or 90 days, whichever is longer, after administration of the last dose of IP, and their partners must be willing to use a highly effective method of contraception (e.g. IUD, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or a tubal ligation) from screening through 5 half-lives or 90 days after administration of the last dose of IP.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Poor metabolisers of CYP 2D6 substrates, as defined after genotyping assessment at screening.
- •2.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 until follow up.
- •3.Any current, clinically significant, known medical condition that would affect sensitivity to cold (such as atherosclerosis, Raynaud’s disease, urticaria, hypothyroidism) or pain (including pain disorders, such as chronic low back pain and osteoarthritis, or diseases or conditions that cause pain, hypaesthesia, hyperalgesia, allodynia, paraesthesia, neuropathy, etc.), in the opinion of the investigator.
- •4.Subjects indicating pain test intolerability at Screening or achieving pain tolerance at >80% of maximum input intensity for the cold pressor pain test.
- •5.Clinically significant illness or disease (e.g., psychiatric disorders, disorders of the gastrointestinal tract, liver [excluding Gilbert’s syndrome], kidney [including nephrectomy], respiratory system, endocrine system, haematological system, neurological system, or cardiovascular system, dermatologic condition, clinically significant infection within 2 weeks of dosing, or subjects who have a congenital abnormality in metabolism), or any clinically significant abnormal symptom or organ impairment, as judged by the Investigator, found by medical history, physical examinations, vital signs, electrocardiogram (ECG) finding, or either abnormal laboratory values or laboratory test results at Screening or Baseline.
- •6.Any finding that may compromise the safety of the subject or affect their ability to adhere to the protocol requirements (e.g., difficulty with venous access or fear of needles).
- •7.Presence of any condition in which an opioid is contraindicated (e.g., opioid intolerance, significant respiratory depression, acute or severe bronchial asthma, gastrointestinal ileus, etc.).
- •8.A prolonged corrected QT interval (Fridericia-corrected QT interval [QTcF] >450 ms in males and >470 in females) demonstrated on ECG at Screening or Baseline.
- •9.A history of risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of long QT syndrome). A history of myocardial infarction, ischaemic heart disease, or cardiac failure at Screening. History of clinically significant arrhythmia or uncontrolled arrhythmia as determined by the Investigator at Screening.
- •10.Left bundle branch block at Screening or Baseline.
- •11.Systolic blood pressure (BP) >140 or <90 mmHg or diastolic BP >90 or <50 mmHg at Screening or Baseline, or history of clinically significant orthostatic hypotension.
- •12.Heart rate (HR) <45 beats per minute (bpm) or >100 bpm at Screening or Baseline.
- •13.Demonstrated allergic reactions (e.g., food, drug, atopic reactions, or asthmatic episodes) which, in the opinion of the Investigator, interfere with the subject’s ability to participate in the trial.
- •14.Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (Anti-HBc), hepatitis C antibodies (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at Screening.
- •15.Use of nicotine-containing products within 4 weeks before the Screening visit and not able to withhold from smoking during the study.
- •16.History of opioid use disorder per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) classification, or other drug/substance or alcohol dependency or abuse before Screen
研究者
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