A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult Male Participants

Lundbeck

Status and phase

Completed

Phase 1

Conditions

Healthy Young Men

Treatments

Drug: [11C]-Lu AF90103

Study type

Interventional

Funder types

Industry

Identifiers

NCT05306366

19739A

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.