Binding of Lu AG06466 in the Brain in Healthy Men

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Lundbeck

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Lu AG06466

Study type

Interventional

Funder types

Industry

Identifiers

NCT04419636
18454A

Details and patient eligibility

About

A study to learn how Lu AG06466 and one of its break down products binds in the brain after single and repeated dosing

Full description

The study will be conducted in two Parts. Part A: cross over, fed/fasted determined by randomized sequence Part B: sequential group PET scans will be used to quantify MAGL occupancy

Enrollment

16 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • body weight ≥60 kg.
  • body mass index ≥18.5 and ≤27 kg/m2.
  • waist circumference ≤94 cm.
  • The subject has a normal sMRI performed during the screening period.
  • The subject is suitable for radial artery blood sampling and cannulation as demonstrated by the Allen test.
  • Subject must be healthy as assessed using detailed medical history, laboratory tests, and physical examination.
  • The subject must make use of contraception.

Exclusion criteria

The subject is left handed.

Other in- and exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Part A Single doses
Experimental group
Description:
Lu AG06466 in fast and fed state
Treatment:
Drug: Lu AG06466
Part B Repeated doses
Experimental group
Description:
Lu AG06466 after light meal
Treatment:
Drug: Lu AG06466

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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