Clinical trial NCT05306366: A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult Male Participants
Official title: Interventional Open-Label Positron Emission Tomography Study Investigating Blood-Brain-Barrier Penetration and Pharmacokinetic Properties of [11C]-Lu AF90103 in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Young Men
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2022-04-01
Enrollment: 8
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 exclusion criteria may apply.

Primary outcomes:
measure: Area Under the Time-Activity Curves for Brain up to 90 Minutes (AUCbrain 0-90 min)
timeFrame: Day 1 (predose and up to 90 minutes postdose)
measure: Area Under the Blood Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCblood 0-90 min)
timeFrame: Day 1 (predose and up to 90 minutes postdose)
measure: Area Under the Plasma Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCplasma 0-90 min)
timeFrame: Day 1 (predose and up to 90 minutes postdose)
measure: Whole Brain-to-Plasma Ratio Expressed by AUCbrain 0-90 min/AUCplasma 0-90 min
timeFrame: Day 1 (predose and up to 90 minutes postdose)
measure: Total Distribution Volume in the Whole Brain (VT brain)
timeFrame: Day 1 (predose and up to 90 minutes postdose)
measure: Ratio Between the Free Concentrations [11C]-Lu AF90103 in Brain Tissue and Plasma (Kp,uu)
timeFrame: Day 1 (predose and up to 90 minutes postdose)
Secondary outcomes:
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Trial Alliance
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: