[18F]MC225 PET to Evaluate Gender Differences in BBB P-gp Function

University Medical Center Groningen (UMCG)

Status: Not yet enrolling

Conditions: Gender

Treatments: Drug: [18F]MC225

Study type: Interventional

Funder types: Other

Identifiers

NCT05618119

11323

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Male

Active Comparator group

Description:

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

Treatment:

Drug: [18F]MC225

Female

Active Comparator group

Description:

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

Treatment:

Drug: [18F]MC225