NCT05320302

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

April 1, 2022

Last Update Submit

July 12, 2022

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

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

    Day 1

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

    Day 1

Study Arms (1)

[11C]-Lu AF88370

EXPERIMENTAL

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

Drug: [11C]-Lu AF88370

Interventions

[11C]-Lu AF88370DRUG

PET ligand in a single intravenous bolus injection

[11C]-Lu AF88370

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Invicro

London, W12 0NN, United Kingdom

Location

Study Officials

  • Email contact via H. Lundbeck A/S

    H. Lundbeck A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2022

First Posted

April 11, 2022

Study Start

March 31, 2022

Primary Completion

June 15, 2022

Study Completion

June 20, 2022

Last Updated

July 14, 2022

Record last verified: 2022-07

Locations

GB(1)