NCT04538014

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_1 healthy

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

August 24, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2020

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

August 25, 2020

Last Update Submit

February 23, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Total distribution volume (VT) of [11C]-Lu AF88434

    Whole-brain distribution volume

    At baseline and post-dose on Day 1

  • C(PET) of Lu AF88434

    Mean plasma concentration of Lu AF88434 during the post-dose PET measurement

    Day 1

  • Area Under Curve (AUC(0-inf)) of Lu AF88434

    Area under the plasma concentration time curve of Lu AF88434 from zero to infinity

    Day 1

  • Cmax of Lu AF88434

    Maximum observed plasma concentration of Lu AF88434

    Day 1

Study Arms (1)

Lu AF88434

EXPERIMENTAL
Drug: Lu AF88434Drug: [11C]-Lu AF88434

Interventions

Lu AF88434DRUG

Oral solution

Lu AF88434
[11C]-Lu AF88434DRUG

\[11C\]-Lu AF88434, and a radioactive dose not exceeding 400 MBq at each PET examination, intravenous bolus injection

Lu AF88434

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel International Northwick Park Hospital (Level 7)

Middlesex, HA1 3UJ, United Kingdom

Location

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    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

August 25, 2020

First Posted

September 3, 2020

Study Start

August 24, 2020

Primary Completion

October 21, 2020

Study Completion

October 21, 2020

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

GB(1)