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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Lu AG06466

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Invicro, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Lu AG06466 will be administered per dose and schedule specified in the arm description.
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; Lu AG06466 will be administered per dose and schedule specified in the arm description.

What is the study measuring?

Primary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): August 18, 2022
• Study Completion (Actual): August 29, 2022

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19941A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No