Healthy Participants
Conditions
Brief summary
The main goals of the study are to assess uptake and distribution of Lu AF88370 in the brain when given at tracer levels (microdose) in healthy young men.
Interventions
DRUG[11C]-Lu AF88370
PET ligand in a single 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 participant has a body mass index (BMI) ≥18.5 and ≤30.0 kilograms (kg)/square meter (m\^2) at the Screening Visit. * The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical and neurological examination, vital signs, an ECG, and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests.
Exclusion criteria
* The participant has taken disallowed medication \<1 week 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 had surgery or trauma with significant blood loss \<6 months prior to the first dose of the study drug. * The participant is exposed to significant levels of ionising radiation at work. Note: Other inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whole Brain Total Distribution Volume (VT) of [11C]-Lu AF88370 | Day 1 |
| VT of [11C]-Lu AF88370 in Regions of Interest (ROI) | Day 1 |
Countries
United Kingdom
Outcome results
None listed