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CompletedNCT05219838Updated Sep 9, 2022

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

A Phase 1 interventional study of Lu AG06466 in Healthy Participants, sponsored by H. Lundbeck A/S. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-09.

Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2022, 4 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Lu AG06466 Low Dose

    Participants will receive Lu AG06466 low dose capsule orally once daily for 6 days approximately 30 minutes following a light meal.

    Drug: Lu AG06466

  • Experimental
    Lu AG06466 High Dose

    Participants will receive Lu AG06466 high dose capsule orally once daily for 6 days approximately 30 minutes following a light meal.

    Drug: Lu AG06466

Interventions

  • DrugLu AG06466

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

06

What researchers measure

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)

07

Study locations

1 site
  • Invicro, LLC
    New Haven, Connecticut 06510, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05219838
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Feb 2, 2022
Start date
Jan 18, 2022
Primary completion
Aug 18, 2022
Completion
Aug 29, 2022
Last update
Sep 9, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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