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

NCT05618119 | Unknown DMC

• 1 other identifier: 11323
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gender

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PET kinetic modeling outcome parameters [18F]MC225

  volume of distribution, K1, k2

  60 minutes after administration [18F]MC225

Secondary Outcomes (1)

• PET kinetic modeling outcome parameters [15O]H2O

  10 minutes after administration of [15O]H2O

Study Arms (2)

Male

ACTIVE COMPARATOR

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

Drug: [18F]MC225

Female

ACTIVE COMPARATOR

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

Drug: [18F]MC225

Interventions

[18F]MC225 DRUG

\[18F\]MC225 PET scan

Female; Male

Eligibility Criteria

• Age: 50 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Related Publications (1)

• Salvi de Souza G, Mossel P, Somsen JF, Providencia L, Bartels AL, Willemsen ATM, Dierckx RAJO, Furini CRG, Lammertsma AA, Tsoumpas C, Luurtsema G. Evaluating image-derived input functions for cerebral [18F]MC225 PET studies. Front Nucl Med. 2025 Jun 5;5:1597902. doi: 10.3389/fnume.2025.1597902. eCollection 2025.

  PMID: 40538986 DERIVED

MeSH Terms

Conditions

Coitus

Interventions

MC225 compound

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Central Study Contacts

Pascalle Mossel, Msc

CONTACT

+3150 361 6161; p.mossel@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Two groups of healthy volunteers (5 male, 5 female)

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 16, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share