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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2022-06-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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[11C]-Lu AF88370

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

Group Type EXPERIMENTAL

[11C]-Lu AF88370

Intervention Type DRUG

PET ligand in a single intravenous bolus injection

Interventions

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[11C]-Lu AF88370

PET ligand in a single intravenous bolus injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes