The Impact of Gender Differences in P-glycoprotein Function Measured With [18F]MC225 and PET
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- PET kinetic modeling outcome parameters [18F]MC225
研究概览
简要总结
P-gp is one of the main efflux transporters at the blood-brain barrier and is responsible for the transport of a variety of neurotoxic substances, including pharmaceuticals. Multiple studies report gender differences in therapeutic outcomes, toxicity and side effects for many drug agents. P-gp plays an important role in the bio-availability, drug distribution, metabolism and elimination of pharmaceuticals labelled as P-gp substrates (e.g. the majority of antidepressants and antipsychotics). A difference in P-gp function was already reported in hepatic P-gp expression. The aim of the current study is to evaluate the influence of gender on cerebral P-gp function. Outcomes of this study can be of great importance in gender-based prescription of P-gp substrate pharmaceuticals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
排除标准
- •Use of medication with a known effect on the BBB P-glycoprotein transporter
- •Any history of neurological or psychiatric conditions affecting the BBB P-glycoprotein function
研究组 & 干预措施
Male
5 male participants will undergo a [18F]MC225 PET scan
干预措施: [18F]MC225 (Drug)
Female
5 female participants will undergo a [18F]MC225 PET scan
干预措施: [18F]MC225 (Drug)
结局指标
主要结局
PET kinetic modeling outcome parameters [18F]MC225
时间窗: 60 minutes after administration [18F]MC225
volume of distribution, K1, k2
次要结局
- PET kinetic modeling outcome parameters [15O]H2O(10 minutes after administration of [15O]H2O)
研究者
Gert Luurtsema
Prof.
University Medical Center Groningen
