EUCTR2016-000216-14-GB进行中（未招募）1 期
A Phase 1, single-centre, double-blind, placebo-controlled crossover study to assess the pharmacoMRI effects of AUT00206 in healthy male participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Male aged 18 to 45 years, inclusive at Visit 1
- •Healthy on the basis of medical history, psychiatric history, physical examination, vital signs, 12-lead electrocardiogram (ECG), haematology, blood chemistry and urinalysis within 6 weeks of Visit 2
- •Right-handed
- •Not a regular smoker (maximum 5 cigarettes per week or equivalent)
- •Competent English speakers
- •Acceptable weight as defined by Body Mass Index (BMI) (weight [kg]/height [m]²) range of 18 to 30 kg/m², inclusive at Visit Participants with partner(s) of childbearing potential must take appropriate precautions to avoid fathering a child from Visit 1 until 4 months after the last dose of study drug and use barrier contraception, in addition to their partner(s) using another method. Acceptable forms of contraception are as follows:
- •Barrier methods: condoms, diaphragms, cervical caps; with a spermicide foam, gel, film, cream or suppository;
- •Non-hormone containing intrauterine methods: intrauterine devices or systems.
- •Provision of written informed consent before initiation of any study related procedures.
- •Be able to understand and comply with the requirements of the study, as judged by the Investigator.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of positive test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV)-1 or HIV-2.
- •Sitting (5 minutes) blood pressure outside the ranges of 90 to 150 mmHg systolic, inclusive, and 60 to 90 mmHg diastolic, inclusive, unless judged not clinically significant by the responsible physician.
- •Corrected QT interval (QTcF) > 450 msec (based on the Fridericia correction where QTcF = QT/RR0.33).
- •Known contraindication to the use of ketamine
- •Participants in whom an elevation of blood pressure would constitute a serious hazard
- •Hypersensitivity to the drug or its components
- •Participants with severe coronary or myocardial disease, cerebrovascular accident or cerebral trauma
- •History of, or presents (in the opinion of the responsible physician) with, significant neurological or psychiatric conditions (such as stroke, traumatic brain injury, depression, epilepsy, space occupying lesions, multiple sclerosis, Parkinson’s disease, vascular dementia, transient ischemic attack, schizophrenia, blackouts requiring hospitalisation).
- •History of, or current condition of, migraine headaches or has undergone operations to the head.
- •History of significant claustrophobia.
- •Recreational drug use within 3 months prior to Visit 1.
- •Intake of more than 21 units of alcohol weekly.
- •Positive alcohol breath test at Visit 1 or Visit 2.
- •Positive urine drug screen at Visit 1 or Visit 2.
- •Consumption of large amounts of caffeinated drinks (more than 8 cups of standard caffeinated drinks [tea, instant coffee] or 6 cups of stronger coffee or other drinks containing methylxanthines such as Coca Cola or Red Bull per day).
- •Consumption of any food or any drinks containing cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges within 3 days prior to Visit 2.
- •Use of a prescription medicine in the 28 days before Visit 2, unless the responsible physician considers that it would not interfere with the study (e.g. acetaminophen).
- •Use of an over-the-counter medicine, with the exception of acetaminophen (paracetamol), in the 7 days before Visit 2, unless the responsible physician considers that it would not interfere with the study.
- •Has participated in another study and/or taken experimental drugs and/or used experimental medical devices within 30 days of Visit 1 or within a period less than 5 times the drug’s half-life, whichever is longer
- •Previous randomisation in the present study.
- •Fulfils any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants).
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