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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Lu AG06466

Study type: Interventional

Funder types: Industry

Identifiers

NCT05219838

19941A

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Lu AG06466 Low Dose

Experimental group

Description:

Participants will receive Lu AG06466 low dose capsule orally once daily for 6 days approximately 30 minutes following a light meal.

Treatment:

Drug: Lu AG06466

Lu AG06466 High Dose

Experimental group

Description:

Participants will receive Lu AG06466 high dose capsule orally once daily for 6 days approximately 30 minutes following a light meal.

Treatment:

Drug: Lu AG06466