A Brain Imaging PET Study of [11C]-Lu AF88370 in Healthy Adult Male Participants

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: [11C]-Lu AF88370

Study type: Interventional

Funder types: Industry

Identifiers

NCT05320302

2021-005082-40 (EudraCT Number)

19874A

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 20 to 55 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 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

[11C]-Lu AF88370

Experimental group

Description:

Participants will receive \[11C\]-Lu AF88370 via an intravenous cannula on Day 1.

Treatment:

Drug: [11C]-Lu AF88370