NL-OMON50921已完成不适用
A methodology study to characterize 2-AG as a potential pharmacological biomarker in healthy human subjects for future clinical trials with a central MAGL inhibitor - Characterization of 2-AG as a potential biomarker
适应症
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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Healthy, male and female subjects between 25-65 of age, inclusive. For cohort
- •2: between 40 and 75 years of age, inclusive.
- •- Female participants must be postmenopausal or must be on hormonal
- •contraception for at least 6 months regulating the menstrual cycle.
- •- Subjects must have a BMI between > 18.0 and 30.0 kg/m2, inclusive
- •(BMI*<=*weight/height2).
- •- Subject must be healthy based on physical examination, medical history, vital
- •signs, and 12-lead Electrocardiogram (ECG). Minor abnormalities in ECG, which
- •are not considered to be of clinical significance by the investigator, are
- •acceptable.
- •- Subjects must be healthy based on clinical laboratory tests performed at
- •screening. If the results of the serum chemistry panel, hematology, or
- •urinalysis are outside the normal reference ranges, the subject may be included
- •only if the investigator judges the abnormalities to be not clinically
- •significant. This determination must be recorded in the subject's source
- •documents and initialed by the sub investigator.
- •- Subjects must be willing to adhere to the prohibitions and restrictions
- •specified in the protocol.
- •- Each subject must sign an informed consent form (ICF) indicating that he or
- •she understands the purpose and procedures required for the study and are
- •willing to participate in the study.
- •- Subjects must be willing to undergo intrathecal insertion of the spinal
- •catheter for 16 hours ±2.
- •- Agree to avoid any strenuous exercise from screening until the last day at
- •the clinical research unit.
排除标准
- •- Pregnant woman.
- •- Past or present history of any clinically relevant psychiatric disorder as
- •classified according to DSM-IV or DSM 5, mood, anxiety and psychotic disorders
- •in particular.
- •- Subject has a history of drug or alcohol use disorder according to DSM-IV or
- •DSM 5 within 12 months before screening or has a positive test result(s) for
- •alcohol and/or drugs of abuse (including but not limited to: opiates (including
- •methadone), cocaine, amphetamines, methamphetamines, cannabinoids,
- •barbiturates, and benzodiazepines) at screening or admission to the clinical
- •- Significant coagulation abnormality (e.g. hemophilia, platelet counts less
- •than the lower limit of normal or clinically significant elevation in PT or PTT
- •at screening), or has a medical condition requiring treatment with an
- •anticoagulant (e.g. warfarin) or with two or more antiplatelet agents. Platelet
- •counts between 125,000 and 150,000/microliter are permissible as long as the
- •investigator confirms there is no evidence of current bleeding diathesis or
- •coagulopathy.
- •- Subject has abnormalities upon fundoscopy indicating an increased
- •Intracranial Pressure (ICP), unless assessed as safe by principal investigator
- •when no further evidence is present indicating ICP.
- •- History of clinically significant back pathology and/or back injury (e.g.
- •degenerative disease, spinal deformity, or spinal surgery) that may predispose
- •to complications or technical difficulty with the spinal catheter.*
- •- Subject smokes cigarettes (or equivalent) and/or has used nicotine-based
- •products within 3*months prior to spinal catheter insertion ; positive cotinine
- •test at screening and admission.
- •- Subject has a history of heparin allergy.
- •- Subject has undergone major lifestyle changes in the previous 6 months:
- •significant weight loss > 5kg or started a specific diet which could
- •potentially result in weight loss.
- •- Vulnerable subjects (e.g., a person kept in detention or a person under
- •guardianship).
- •- Subject is unable to read and understand the consent forms, complete
- •study-related procedures, and/or communicate with the study staff.
- •- Unsuitable veins for cannulation and/or repeated venepuncture.
- •- Diagnosis or suspicions of any sleep disorder in the last 6 months or current
- •complaints of sleep disturbance, irregular sleep schedule or shift work;
- •habitual daytime naps; travel across time zones in the last 4 weeks or daytime
- •symptoms attributable to unsatisfactory sleep.
- •- Use of a prescription medicine and or over-the-counter medicine influencing
- •the sleeping habits (such as benzodiazepines, melatonin) or occasional use
- •(last 6 months) of cannabis (in all its forms including the use of cannabidiol
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