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Completed

NCT Number: NCT05306366

A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult Male Participants

The main goals of the study are to assess uptake and distribution of Lu AF90103 in the brain when given at tracer levels (microdose) in healthy young men.

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Key information

Conditions

Healthy Young Men

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Karolinska Trial Alliance

Huddinge, 141 86, Sweden

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 examination; vital signs; an electrocardiogram (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 or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
  • The participant has had surgery or trauma with significant blood loss <3 months prior to the first dose of study drug.
  • The participant is exposed to significant levels of ionizing radiation at work. Note: Other inclusion and exclusion criteria may apply.

Treatment and study plan

[11C]-Lu AF90103

Drug

PET ligand administrated as a single intravenous bolus injection

Primary outcomes

  1. Area Under the Time-Activity Curves for Brain up to 90 Minutes (AUCbrain 0-90 min)

    Time frame: Day 1 (predose and up to 90 minutes postdose)

  2. Area Under the Blood Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCblood 0-90 min)

    Time frame: Day 1 (predose and up to 90 minutes postdose)

  3. Area Under the Plasma Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCplasma 0-90 min)

    Time frame: Day 1 (predose and up to 90 minutes postdose)

  4. Whole Brain-to-Plasma Ratio Expressed by AUCbrain 0-90 min/AUCplasma 0-90 min

    Time frame: Day 1 (predose and up to 90 minutes postdose)

  5. Total Distribution Volume in the Whole Brain (VT brain)

    Time frame: Day 1 (predose and up to 90 minutes postdose)

  6. Ratio Between the Free Concentrations [11C]-Lu AF90103 in Brain Tissue and Plasma (Kp,uu)

    Time frame: Day 1 (predose and up to 90 minutes postdose)

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional Open-Label Positron Emission Tomography Study Investigating Blood-Brain-Barrier Penetration and Pharmacokinetic Properties of [11C]-Lu AF90103 in Healthy Young Men

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 1, 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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