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

Sponsor

University Medical Center Groningen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05618119

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gender	Drug: [18F]MC225	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Medical Center Groningen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gert Luurtsema, Prof., University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT05618119

Other Study ID Numbers:

11323

First Posted:

Nov 16, 2022

Last Update Posted:

Nov 16, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gert Luurtsema, Prof., University Medical Center Groningen

Study Results

No Results Posted as of Nov 16, 2022