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Completed

NCT Number: NCT04538014

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

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

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International Northwick Park Hospital (Level 7)

Middlesex, HA1 3UJ, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lu AF88434

Drug

Oral solution

[11C]-Lu AF88434

Drug

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

Primary outcomes

  1. Total distribution volume (VT) of [11C]-Lu AF88434

    Time frame: At baseline and post-dose on Day 1

    Whole-brain distribution volume

  2. C(PET) of Lu AF88434

    Time frame: Day 1

    Mean plasma concentration of Lu AF88434 during the post-dose PET measurement

  3. Area Under Curve (AUC(0-inf)) of Lu AF88434

    Time frame: Day 1

    Area under the plasma concentration time curve of Lu AF88434 from zero to infinity

  4. Cmax of Lu AF88434

    Time frame: Day 1

    Maximum observed plasma concentration of Lu AF88434

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 3, 2020
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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