Healthy Young Men
Conditions
Brief summary
The main goals of the study are to assess uptake and distribution of Lu AF90103 in the brain when given at tracer levels (microdose) in healthy young men.
Interventions
DRUG[11C]-Lu AF90103
PET ligand administrated as 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 45 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 examination; vital signs; an electrocardiogram (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 or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. * The participant has had surgery or trauma with significant blood loss \<3 months prior to the first dose of study drug. * The participant is exposed to significant levels of ionizing radiation at work. Note: Other inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio Between the Free Concentrations [11C]-Lu AF90103 in Brain Tissue and Plasma (Kp,uu) | Day 1 (predose and up to 90 minutes postdose) |
| Area Under the Time-Activity Curves for Brain up to 90 Minutes (AUCbrain 0-90 min) | Day 1 (predose and up to 90 minutes postdose) |
| Area Under the Blood Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCblood 0-90 min) | Day 1 (predose and up to 90 minutes postdose) |
| Area Under the Plasma Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCplasma 0-90 min) | Day 1 (predose and up to 90 minutes postdose) |
| Whole Brain-to-Plasma Ratio Expressed by AUCbrain 0-90 min/AUCplasma 0-90 min | Day 1 (predose and up to 90 minutes postdose) |
| Total Distribution Volume in the Whole Brain (VT brain) | Day 1 (predose and up to 90 minutes postdose) |
Countries
Sweden
Outcome results
None listed