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

Gender Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05618119
• Other study ID #: 11323
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2022
• Source: University Medical Center Groningen
• Contact: Pascalle Mossel, Msc
• Phone: +3150 361 6161
• Email: p.mossel[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gender

Intervention

Drug:
• [18F]MC225
[18F]MC225 PET scan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET kinetic modeling outcome parameters [18F]MC225	volume of distribution, K1, k2	60 minutes after administration [18F]MC225
Secondary	PET kinetic modeling outcome parameters [15O]H2O	K1 to evaluate Cerebral Blood Flow (CBF)	10 minutes after administration of [15O]H2O