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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05219838

Enrollment

Registered

2022-02-02

Start date

2022-01-18

Completion date

2022-08-29

Last updated

2022-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Brief 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.

Interventions

DRUGLu AG06466

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

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

* 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

Design outcomes

Primary

Measure	Time frame
Plasma Concentration of Lu AG06466 and Lu AG06988	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)
Cerebrospinal Fluid (CSF) Concentration of Lu AG06466 and Lu AG06988	Pre-dose and on Day 6 (3 hours post-dose)
Central MAGL Occupancy (%) Measured Using [18F]MNI-1188 PET Imaging	2 to 4 hours post-dose on Day 5
CSF Concentrations of 2-arachidonolylglycerol (2-AG) (1-arachidonolylglycerol [1-AG]+2-AG), 2-oleoylglycerol (2-OG), and arachidonic acid (AA)	Day 6 (3 hours post-dose)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026