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

Interventional, Open-Label, Positron Emission Tomography (PET) Study With [11C]-Lu AF88370 Investigating Blood-Brain Barrier Penetration of Lu AF88370 in Healthy Men

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: [11C]-Lu AF88370

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0NN
    • Invicro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [11C]-Lu AF88370; Participants will receive [11C]-Lu AF88370 via an intravenous cannula on Day 1.	Drug: [11C]-Lu AF88370; PET ligand in a single intravenous bolus injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Whole Brain Total Distribution Volume (VT) of [11C]-Lu AF88370	Day 1
VT of [11C]-Lu AF88370 in Regions of Interest (ROI)	Day 1

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19874A; 2021-005082-40 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No