Status:
COMPLETED
A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult Male Participants
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Healthy Young Men
Eligibility:
MALE
20-45 years
Phase:
PHASE1
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
- 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
- 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.
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05306366
Start Date
March 23 2022
End Date
June 7 2022
Last Update
July 14 2022
Active Locations (1)
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1
Karolinska Trial Alliance
Huddinge, Sweden, 141 86