NCT03826134已完成早期 1 期
Interventional, Phase I, Open-label, First in Human, Single-center Positron Emission Tomography (PET) Study Investigating Test-retest Properties of [11C]-PXT012253 as a Radiotracer in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Binding potential (BPND) in the ROI's
研究概览
简要总结
This study evaluates the usefulness of a PET radioligand to estimate the binding on the mGlu4 receptor in the brain. mGlu4 has been proposed as a therapeutic target in Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects age 20-50 inclusive
- •Body mass index (BMI) between 19 and 30 kg/m2
- •Normal sMRI scan, performed within 3 months, as judged by the investigator
- •The subject is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, ECG, and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests
- •Women of childbearing potential and men whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter
- •A propensity to tolerate confined spaces for prolonged periods
- •Suitability for radial and/or brachial artery blood sampling and cannulation
排除标准
- •History of clinically significant cardio-or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the investigator
- •The subject has 1 or more clinical laboratory test values outside the reference range, which in the opinion of the investigator are clinically significant
- •Screening supine blood pressure >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility
- •The subject has a resting pulse <=50 or >=100 bpm at the Screening Visit
- •The subject has a QTc interval >430 ms (Bazett's or Fridericia's correction) at the Screening Visit or at he Baseline Visit, as calculated by the ECG equipment and evaluated by the investigator. The ECG may be repeated if any of the values are out-of-range or abnormal
- •The subject is pregnant or breastfeeding
- •Habitual use of nicotine products and addictive substances
- •Any finding of significance on MRI scans as judged by the investigator.
- •Any previous PET measurements for scientific purposes
- •Use of CNS active drugs and/or NSAIDs 1 month prior to the first PET examination
- •The subject is exposed to significant level of ionizing radiation at work
- •The subject has undergone any clinical procedures involving significant exposure to radiation (excluding dental X-ray and common X-rays of the chest or extremities)
- •The subject has received radio labeled material less than 12
研究组 & 干预措施
[11C]-PXT012253
Experimental
干预措施: [11C]PXT012253 (Drug)
结局指标
主要结局
Binding potential (BPND) in the ROI's
时间窗: Up to 3 days
Total distribution volumes (VT) for each region of interest (ROI)
时间窗: Up to 3 days
次要结局
未报告次要终点
研究者
研究点 (1)
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