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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05320302
• Other study ID #: 19874A
• Secondary ID: 2021-005082-40
• Status: Completed
• Phase: Phase 1
• Start date: March 31, 2022
• Est. completion date: June 20, 2022

Study information

• Verified date: July 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 20, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• [11C]-Lu AF88370
PET ligand in a single intravenous bolus injection

Locations

Country	Name	City	State
United Kingdom	Invicro	London

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole Brain Total Distribution Volume (VT) of [11C]-Lu AF88370		Day 1
Primary	VT of [11C]-Lu AF88370 in Regions of Interest (ROI)		Day 1