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

NCT ID: NCT04538014

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-24
• Study Completion Date: 2020-10-21

Brief Summary

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

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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lu AF88434

Group Type: EXPERIMENTAL

Lu AF88434

Intervention Type: DRUG

Oral solution

[11C]-Lu AF88434

Intervention Type: DRUG

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

Interventions

Lu AF88434

Oral solution

Intervention Type: DRUG

[11C]-Lu AF88434

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

Parexel International Northwick Park Hospital (Level 7)

Middlesex, , United Kingdom

Countries

United Kingdom

Other Identifiers

18426A

Identifier Type: -

Identifier Source: org_study_id