NCT04538014

A Study in Healthy Men to Investigate Uptake and Distribution of Lu AF88434 in the Brain

Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-Lu AF88434 Investigating Blood-brain Barrier Penetration, Safety, and Tolerability of Lu AF88434 in Healthy Men

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will investigate how much of Lu AF88434 will get into the blood and the brain in healthy men

Detailed description

The study consists of the following parts: * a Screening Visit * an MRI scanning visit * an in-clinic stay which includes: a Safety Baseline one day prior to dosing, a one-day \[11C\]-Lu AF88434 imaging session consisting of a baseline PET measurement and a post-dose PET measurement conducted after the administration of a single oral dose of Lu AF88434, pharmacokinetic (PK) sampling and safety assessments throughout the period * a Follow-up Visit 7 days after dosing

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lu AF88434	Oral solution
DRUG	[11C]-Lu AF88434	\[11C\]-Lu AF88434, and a radioactive dose not exceeding 400 MBq at each PET examination, intravenous bolus injection

Timeline

• Start date: 2020-08-24
• Primary completion: 2020-10-21
• Completion: 2020-10-21
• First posted: 2020-09-03
• Last updated: 2021-02-24

Locations

1 site across 1 country: United Kingdom