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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05219838
• Other study ID #: 19941A
• Status: Completed
• Phase: Phase 1
• Start date: January 18, 2022
• Est. completion date: August 29, 2022

Study information

• Verified date: September 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 29, 2022
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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

Locations

Country	Name	City	State
United States	Invicro, LLC	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Cerebrospinal Fluid (CSF) Concentration of Lu AG06466 and Lu AG06988		Pre-dose and on Day 6 (3 hours post-dose)
Primary	Central MAGL Occupancy (%) Measured Using [18F]MNI-1188 PET Imaging		2 to 4 hours post-dose on Day 5
Primary	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)