[18F]MC225 PET to Evaluate Gender Differences in BBB P-gp Function
- Registration Number
- NCT05618119
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Healthy volunteers
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Male [18F]MC225 5 male participants will undergo a \[18F\]MC225 PET scan Female [18F]MC225 5 female participants will undergo a \[18F\]MC225 PET scan
- Primary Outcome Measures
Name Time Method PET kinetic modeling outcome parameters [18F]MC225 60 minutes after administration [18F]MC225 volume of distribution, K1, k2
- Secondary Outcome Measures
Name Time Method PET kinetic modeling outcome parameters [15O]H2O 10 minutes after administration of [15O]H2O K1 to evaluate Cerebral Blood Flow (CBF)