A Brain Imaging PET Study of [11C]-Lu AF88370 in Healthy Adult Male Participants
- Registration Number
- NCT05320302
- Lead Sponsor
- H. Lundbeck A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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 exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [11C]-Lu AF88370 [11C]-Lu AF88370 Participants will receive \[11C\]-Lu AF88370 via an intravenous cannula on Day 1.
- Primary Outcome Measures
Name Time Method Whole Brain Total Distribution Volume (VT) of [11C]-Lu AF88370 Day 1 VT of [11C]-Lu AF88370 in Regions of Interest (ROI) Day 1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Invicro
🇬🇧London, United Kingdom