A Study in Healthy Men to Investigate Uptake and Distribution of Lu AF88434 in the Brain

February 23, 2021 updated by: H. Lundbeck A/S

Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-Lu AF88434 Investigating Blood-brain Barrier Penetration, Safety, and Tolerability of Lu AF88434 in Healthy Men

This study will investigate how much of Lu AF88434 will get into the blood and the brain in healthy men

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study consists of the following parts:

  • a Screening Visit
  • an MRI scanning visit
  • an in-clinic stay which includes: a Safety Baseline one day prior to dosing, a one-day [11C]-Lu AF88434 imaging session consisting of a baseline PET measurement and a post-dose PET measurement conducted after the administration of a single oral dose of Lu AF88434, pharmacokinetic (PK) sampling and safety assessments throughout the period
  • a Follow-up Visit 7 days after dosing

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Middlesex, United Kingdom, HA1 3UJ
        • Parexel International Northwick Park Hospital (Level 7)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit
  • The subject has a normal MRI performed during the screening period, as judged by the investigator
  • The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests
  • The subject can tolerate confined spaces for prolonged periods of time
  • The subject is suitable for radial artery blood sampling and cannulation

Exclusion Criteria:

  • The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the Investigational Medicinal Product (IMP)

Other in- or exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lu AF88434
Drug: Lu AF88434
Oral solution
Drug: [11C]-Lu AF88434
[11C]-Lu AF88434, and a radioactive dose not exceeding 400 MBq at each PET examination, intravenous bolus injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total distribution volume (VT) of [11C]-Lu AF88434
Time Frame: At baseline and post-dose on Day 1
Whole-brain distribution volume
At baseline and post-dose on Day 1
C(PET) of Lu AF88434
Time Frame: Day 1
Mean plasma concentration of Lu AF88434 during the post-dose PET measurement
Day 1
Area Under Curve (AUC(0-inf)) of Lu AF88434
Time Frame: Day 1
Area under the plasma concentration time curve of Lu AF88434 from zero to infinity
Day 1
Cmax of Lu AF88434
Time Frame: Day 1
Maximum observed plasma concentration of Lu AF88434
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 24, 2020

Primary Completion (ACTUAL)

October 21, 2020

Study Completion (ACTUAL)

October 21, 2020

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (ACTUAL)

September 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 18426A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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