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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lu AF88434; Drug: [11C]-Lu AF88434

• Registration Number: NCT04538014
• Lead Sponsor: H. Lundbeck A/S

Brief 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

Study Timeline

• Study Start: 2020-08-24
• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-03
• Primary Completion: 2020-10-21
• Study Completion: 2020-10-21
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit
• The subject has a normal MRI performed during the screening period, as judged by the investigator
• The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests
• The subject can tolerate confined spaces for prolonged periods of time
• The subject is suitable for radial artery blood sampling and cannulation

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Exclusion Criteria

• The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the Investigational Medicinal Product (IMP)

Other in- or exclusion criteria may apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lu AF88434	Lu AF88434	-
Lu AF88434	[11C]-Lu AF88434	-

Primary Outcome Measures

Name	Time	Method
Total distribution volume (VT) of [11C]-Lu AF88434	At baseline and post-dose on Day 1	Whole-brain distribution volume
C(PET) of Lu AF88434	Day 1	Mean plasma concentration of Lu AF88434 during the post-dose PET measurement
Area Under Curve (AUC(0-inf)) of Lu AF88434	Day 1	Area under the plasma concentration time curve of Lu AF88434 from zero to infinity
Cmax of Lu AF88434	Day 1	Maximum observed plasma concentration of Lu AF88434

Trial Locations

Locations (1)

Parexel International Northwick Park Hospital (Level 7); 🇬🇧 Middlesex, United Kingdom