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临床试验/NCT03903549
NCT03903549已完成1 期

A Positron Emission Tomography (PET) Study to Investigate [18F]D6-FP-DTBZ ([18F]P17-059) for Potential Use as a Radioligand for Vesicular Monoamine Transporter (VMAT2)

Five Eleven Pharma, Inc.1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2022年7月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
4
试验地点
1
主要终点
Regional brain uptake of [18F]P17-057 in Parkinson patients compared healthy volunteers

研究概览

简要总结

This study investigates the initial safety profile of [18F]P17-059 in healthy volunteers including dosimetry determination, and compares regional brain uptake and kinetics of [18F]P17-059 in Parkinson's disease patients with regional brain uptake and kinetics of [18F]P17-059 in healthy volunteers.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
45 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Brain uptake and kinetics in Parkinson patients

Experimental

干预措施: [18F]P17-059 (Drug)

Brain uptake and kinetics in healthy volunteers

Experimental

干预措施: [18F]P17-059 (Drug)

Dosimetry in healthy volunteers

Experimental

干预措施: [18F]P17-059 (Drug)

结局指标

主要结局

Regional brain uptake of [18F]P17-057 in Parkinson patients compared healthy volunteers

时间窗: 0 - 90 minutes post injection

Quantitative estimates of \[18F\]P17-059 uptake in brain - SUV and non-displaceable Binding Potential

Cumulative organ [18F]P17-059 activity for estimates of radiation absorbed dose and effective dose

时间窗: 0 - 240 minutes post injection

Dosimetry

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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