跳至主要内容
临床试验/NCT05618119
NCT05618119尚未招募不适用

The Impact of Gender Differences in P-glycoprotein Function Measured With [18F]MC225 and PET

University Medical Center Groningen0 个研究点目标入组 10 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

5 male participants will undergo a [18F]MC225 PET scan

干预措施: [18F]MC225 (Drug)

Female

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gert Luurtsema

Prof.

University Medical Center Groningen

相似试验