Healthy
Conditions
Brief summary
This study will investigate how much of Lu AF88434 will get into the blood and the brain in healthy men
Detailed 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
Interventions
DRUGLu AF88434
Oral solution
DRUG[11C]-Lu AF88434
\[11C\]-Lu AF88434, and a radioactive dose not exceeding 400 MBq at each PET examination, intravenous bolus injection
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total distribution volume (VT) of [11C]-Lu AF88434 | At baseline and post-dose on Day 1 | Whole-brain distribution volume |
| C(PET) of Lu AF88434 | Day 1 | Mean plasma concentration of Lu AF88434 during the post-dose PET measurement |
| Area Under Curve (AUC(0-inf)) of Lu AF88434 | Day 1 | Area under the plasma concentration time curve of Lu AF88434 from zero to infinity |
| Cmax of Lu AF88434 | Day 1 | Maximum observed plasma concentration of Lu AF88434 |
Countries
United Kingdom
Outcome results
None listed