EUCTR2018-000379-34-NL进行中（未招募）1 期
A pilot study exploring the reproducibility and suitability for multi-center clinical trials of fMRI bold signal during a monetary incentive delay task and arterial spin labeling with and without prior administration of Risperidone
Millennium Pharmaceuticals, Inc. A Takeda Oncology Company0 个研究点目标入组 5 人开始时间: 2018年2月20日最近更新:
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
- 入组人数
- 5
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
- Male
入选标准
- •1. Gender : male
- •2. Age : 18 to 45 years, inclusive, at screening
- •3. Body mass index : 18.0 to 30.0 kg/m2, inclusive
- •4. Body weight : 50 to 100 kg, inclusive
- •5. Status: healthy right handed subjects
- •6. Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject is acceptable.
- •7. All prescribed medication must have been stopped at least 30 days prior to each admission to the clinical research center.
- •8. All over-the-counter (OTC) medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John’s Wort) must have been stopped at least 14 days prior to each admission to the clinical research center. An exception is made for paracetamol, which is allowed up to admission to the clinical research center.
- •9. Good physical and mental health as defined by the absence of active or chronic disease based on medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the PI
- •10. Completion of an MRI safety questionnaire to verify MRI eligibility (including no claustrophobia, history of surgery involving metal implants, metal body piercing, dentures, dental plates or bridges, any implanted device that is electrically, magnetically, and mechanically activated) and to exclude brain abnormalities that may confound the imaging results (such as history of intracranial mass lesion, brain surgery, hydrocephalus, and/or head injury or trauma).
- •11. Willing and able to sign the ICF
- •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 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Employee of PRA or the Sponsor
- •2. History of relevant drug and/or food allergies
- •3. Any contraindication to MRI scanning (eg, claustrophobia, implantable devices)
- •4. Brain or head abnormalities restricting MRI eligibility
- •5. Systolic blood pressure <90 or >149 mmHg and diastolic blood pressure <40 or >90 mmHg
- •6. Notable resting bradycardia (<40 beats per min [bpm]) or tachycardia (>100bpm)
- •7. History or presence of clinically significant ECG abnormalities (normal ranges used for healthy subjects eg, a ventricular rate greater than 100 or less than 35 beats/min, PR interval greater than 220 or less than 120 ms, QRS=120 ms, QTcF=430 ms) or cardiovascular disease (eg cardiac insufficiency, coronary artery disease, cardiomyopathy, hypokalemia, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death)
- •8. Significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis)
- •9. Use of any psychoactive medication, or medications known to have effects on CNS or blood flow
- •10. Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits)
- •11. Habitual caffeine consumption of more than 500 mg per day (approximately more than 6 cups of coffee or equivalent)
- •12. History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
- •13. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening or each admission to the clinical research center
- •14. Positive screen for hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies, or anti human immunodeficiency virus (HIV) 1 and 2 antibodies
- •15. Participation in a drug study within 90 days prior to drug administration in the current study. Participation in more than 3 other drug studies in the 10 months prior to drug administration in the current study
- •16. Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the PI
- •17. Any personal history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures
- •18. Disorders of the central nervous system, cerebrovascular events, Parkinson’s disease, migraine, depression, bipolar disorder, anxiety, and any other psychiatric disorders or behavioural disturbances
- •19. Positive family history of psychosis up to 1st degree relatives
- •20. History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
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