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OpenTrials
Completed

NCT Number: NCT04419636

Binding of Lu AG06466 in the Brain in Healthy Men

A study to learn how Lu AG06466 and one of its break down products binds in the brain after single and repeated dosing

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

UZ Leuven campus Gasthuisberg

Leuven, 3000, Belgium

About this study

The study will be conducted in two Parts. Part A: cross over, fed/fasted determined by randomized sequence Part B: sequential group

PET scans will be used to quantify MAGL occupancy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • body weight ≥60 kg.
  • body mass index ≥18.5 and ≤27 kg/m2.
  • waist circumference ≤94 cm.
  • The subject has a normal sMRI performed during the screening period.
  • The subject is suitable for radial artery blood sampling and cannulation as demonstrated by the Allen test.
  • Subject must be healthy as assessed using detailed medical history, laboratory tests, and physical examination.
  • The subject must make use of contraception.

Exclusion criteria

  • The subject is left handed.

Other in- and exclusion criteria may apply

Treatment and study plan

Lu AG06466

Drug

capsules, orally

Other names: ABX-1431

Primary outcomes

  1. Central monoacylglycerol lipase (MAGL) occupancy

    Time frame: From dosing to 8 hours post-dose

Secondary outcomes

  1. C(PET)

    Time frame: From zero to Day 10

    Average plasma concentration for Lu AG06466 and Lu AG06988 during PET imaging

  2. AUC (0-24)

    Time frame: From zero to 24 hours post-dose

    Area under the plasma concentration curve for Lu AG06466 and Lu AG06988 from zero to 24 hours

  3. Cmax

    Time frame: From zero to 24 hours post-dose

    Maximum observed plasma concentration for Lu AG06466 and Lu AG06988

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-label, Position Emission Tomography (PET) Study Investigating MAGL Occupancy After Single and Multiple Oral Doses of Lu AG06466 in Healthy Male Subjects

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 5, 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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