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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Lu AG06466

• Registration Number: NCT05219838
• Lead Sponsor: H. Lundbeck A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-18
• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-02
• Primary Completion: 2022-08-18
• Study Completion: 2022-08-29
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lu AG06466 Low Dose	Lu AG06466	Participants will receive Lu AG06466 low dose capsule orally once daily for 6 days approximately 30 minutes following a light meal.
Lu AG06466 High Dose	Lu AG06466	Participants will receive Lu AG06466 high dose capsule orally once daily for 6 days approximately 30 minutes following a light meal.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Invicro, LLC; 🇺🇸 New Haven, Connecticut, United States