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

NCT ID: NCT05219838

Last Updated: 2022-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2022-08-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lu AG06466

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Lu AG06466

Intervention Type: DRUG

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

Interventions

Lu AG06466

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Invicro, LLC

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

19941A

Identifier Type: -

Identifier Source: org_study_id