[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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gender
• Intervention / Treatment: Drug: [18F]MC225

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pascalle Mossel, Msc; Phone Number: +3150 361 6161; Email: p.mossel@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Male; 5 male participants will undergo a [18F]MC225 PET scan	Drug: [18F]MC225; [18F]MC225 PET scan
Active Comparator: Female; 5 female participants will undergo a [18F]MC225 PET scan	Drug: [18F]MC225; [18F]MC225 PET scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET kinetic modeling outcome parameters [18F]MC225	volume of distribution, K1, k2	60 minutes after administration [18F]MC225

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET kinetic modeling outcome parameters [15O]H2O	K1 to evaluate Cerebral Blood Flow (CBF)	10 minutes after administration of [15O]H2O

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: PET; P-glycoprotein; MC225; [18F]MC225
• Other Study ID Numbers: 11323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No