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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538014
• Other study ID #: 18426A
• Status: Completed
• Phase: Phase 1
• Start date: August 24, 2020
• Est. completion date: October 21, 2020

Study information

• Verified date: February 2021
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 21, 2020
• Est. primary completion date: October 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lu AF88434
Oral solution
• [11C]-Lu AF88434
[11C]-Lu AF88434, and a radioactive dose not exceeding 400 MBq at each PET examination, intravenous bolus injection

Locations

Country	Name	City	State
United Kingdom	Parexel International Northwick Park Hospital (Level 7)	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

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