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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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