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CompletedNCT05320302Updated Jul 14, 2022

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

A Phase 1 interventional study of [11C]-Lu AF88370 in Healthy Participants, sponsored by H. Lundbeck A/S. Completed at 1 site in United Kingdom. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-14.

Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
20 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 224 studies on the registry; 9 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Browse H. Lundbeck A/S studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    [11C]-Lu AF88370

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

    Drug: [11C]-Lu AF88370

Interventions

  • Drug[11C]-Lu AF88370

    PET ligand in a single intravenous bolus injection

06

What researchers measure

Primary outcomes

  1. Whole Brain Total Distribution Volume (VT) of [11C]-Lu AF88370

    Time frame: Day 1

  2. VT of [11C]-Lu AF88370 in Regions of Interest (ROI)

    Time frame: Day 1

07

Study locations

1 site
  • Invicro
    London, W12 0NN, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05320302
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Apr 11, 2022
Start date
Mar 31, 2022
Primary completion
Jun 15, 2022
Completion
Jun 20, 2022
Last update
Jul 14, 2022

Study contacts

Email contact via H. Lundbeck A/S
study director · H. Lundbeck A/S

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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