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OpenTrials
Completed

NCT Number: NCT05219838

Binding and Effects of Lu AG06466 in the Brain of Healthy Men

This study is being done to learn about the binding of Lu AG06466 and its major breakdown product (Lu AG06988) in the brain of healthy men having received multiple doses of Lu AG06466. As the binding will result in inhibition of an enzyme in the endocannabinoid system called monoacylglycerol lipase (MAGL), the effects on this system will be evaluated both in the blood and cerebrospinal fluid and compared to the binding in the brain.

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Key information

Conditions

Healthy Participants

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Invicro, LLC

New Haven, Connecticut, 06510, United States

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 and ≤30 kilograms (kg)/square meter (m^2) at the screening visit.
  • The participant has a weight of ≥60 kg at the screening visit and baseline visit.
  • The participant has a waist circumference ≤94 centimeters (cm) at the screening visit.

Exclusion criteria

  • The participant has taken disallowed medication <2 weeks 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 or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

Note: Other inclusion and exclusion criteria may apply.

Treatment and study plan

Lu AG06466

Drug

Lu AG06466 will be administered per dose and schedule specified in the arm description.

Primary outcomes

  1. Plasma Concentration of Lu AG06466 and Lu AG06988

    Time frame: Day 5 (pre-dose, per hour before and after positron emission tomography [PET] imaging and per 30 minutes during PET imaging) and on Day 6 (3 hours post-dose)

  2. Cerebrospinal Fluid (CSF) Concentration of Lu AG06466 and Lu AG06988

    Time frame: Pre-dose and on Day 6 (3 hours post-dose)

  3. Central MAGL Occupancy (%) Measured Using [18F]MNI-1188 PET Imaging

    Time frame: 2 to 4 hours post-dose on Day 5

  4. CSF Concentrations of 2-arachidonolylglycerol (2-AG) (1-arachidonolylglycerol [1-AG]+2-AG), 2-oleoylglycerol (2-OG), and arachidonic acid (AA)

    Time frame: Day 6 (3 hours post-dose)

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional , Open-label, Positron Emission Tomography (PET) Study With [18F]-T-401 Investigating MAGL Enzyme Occupancy After Multiple Oral Doses of Lu AG06466

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2022
Registry last updated
Sep 9, 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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