A Study in Healthy Men to Investigate Uptake and Distribution of Lu AF88434 in the Brain

Lundbeck

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: [11C]-Lu AF88434

Drug: Lu AF88434

Study type

Interventional

Funder types

Industry

Identifiers

18426A

Details and patient eligibility

About

This study will investigate how much of Lu AF88434 will get into the blood and the brain in healthy men

Full description

The study consists of the following parts:

a Screening Visit
an MRI scanning visit
an in-clinic stay which includes: a Safety Baseline one day prior to dosing, a one-day [11C]-Lu AF88434 imaging session consisting of a baseline PET measurement and a post-dose PET measurement conducted after the administration of a single oral dose of Lu AF88434, pharmacokinetic (PK) sampling and safety assessments throughout the period
a Follow-up Visit 7 days after dosing

Enrollment

8 patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit
The subject has a normal MRI performed during the screening period, as judged by the investigator
The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests
The subject can tolerate confined spaces for prolonged periods of time
The subject is suitable for radial artery blood sampling and cannulation

Exclusion criteria

The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the Investigational Medicinal Product (IMP)

Other in- or exclusion criteria may apply