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

NCT05219838 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 19941A
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

Lu AG06466 Low Dose

EXPERIMENTAL

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 High Dose

EXPERIMENTAL

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

Lu AG06466 DRUG

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

Lu AG06466 High Dose; Lu AG06466 Low Dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Invicro, LLC

New Haven, Connecticut, 06510, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: January 18, 2022
• Primary Completion: August 18, 2022
• Study Completion: August 29, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Locations

US (1)