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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05618119
Enrollment
10
Registered
2022-11-16
Start date
2023-01-01
Completion date
2025-01-01
Last updated
2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gender

Keywords

P-glycoprotein, MC225, [18F]MC225, PET

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.

Interventions

\[18F\]MC225 PET scan

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Two groups of healthy volunteers (5 male, 5 female)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
PET kinetic modeling outcome parameters [18F]MC22560 minutes after administration [18F]MC225volume of distribution, K1, k2

Secondary

MeasureTime frameDescription
PET kinetic modeling outcome parameters [15O]H2O10 minutes after administration of [15O]H2OK1 to evaluate Cerebral Blood Flow (CBF)

Contacts

Primary ContactPascalle Mossel, Msc
p.mossel@umcg.nl+3150 361 6161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026