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OpenTrials
Completed

NCT Number: NCT05320302

A Brain Imaging PET Study of [11C]-Lu AF88370 in Healthy Adult Male Participants

The main goals of the study are to assess uptake and distribution of Lu AF88370 in the brain when given at tracer levels (microdose) in healthy young men.

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Key information

Conditions

Healthy Participants

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Invicro

London, W12 0NN, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The participant has a body mass index (BMI) ≥18.5 and ≤30.0 kilograms (kg)/square meter (m^2) at the Screening Visit.
  • The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical and neurological examination, vital signs, an ECG, and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests.

Exclusion criteria

  • The participant has taken disallowed medication <1 week prior to the first dose of study drug or <5 half-lives prior to the Screening Visit for any medication taken.
  • The participant has received a COVID-19 vaccination within the last 30 days before receiving first dose of study drug.
  • The participant has had surgery or trauma with significant blood loss <6 months prior to the first dose of the study drug.
  • The participant is exposed to significant levels of ionising radiation at work.

Note: Other inclusion and exclusion criteria may apply.

Treatment and study plan

[11C]-Lu AF88370

Drug

PET ligand in a single intravenous bolus injection

Primary outcomes

  1. Whole Brain Total Distribution Volume (VT) of [11C]-Lu AF88370

    Time frame: Day 1

  2. VT of [11C]-Lu AF88370 in Regions of Interest (ROI)

    Time frame: Day 1

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 AF88370 Investigating Blood-Brain Barrier Penetration of Lu AF88370 in Healthy Men

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2022
Registry last updated
Jul 14, 2022

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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