Binding of Lu AG06466 in the Brain in Healthy Men

NCT ID: NCT04419636

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-29

Study Completion Date

2021-02-16

Brief Summary

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A study to learn how Lu AG06466 and one of its break down products binds in the brain after single and repeated dosing

Detailed Description

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The study will be conducted in two Parts. Part A: cross over, fed/fasted determined by randomized sequence Part B: sequential group

PET scans will be used to quantify MAGL occupancy

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A Single doses

Lu AG06466 in fast and fed state

Group Type EXPERIMENTAL

Lu AG06466

Intervention Type DRUG

capsules, orally

Part B Repeated doses

Lu AG06466 after light meal

Group Type EXPERIMENTAL

Lu AG06466

Intervention Type DRUG

capsules, orally

Interventions

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Lu AG06466

capsules, orally

Intervention Type DRUG

Other Intervention Names

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ABX-1431

Eligibility Criteria

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Inclusion Criteria

* body weight ≥60 kg.
* body mass index ≥18.5 and ≤27 kg/m2.
* waist circumference ≤94 cm.
* The subject has a normal sMRI performed during the screening period.
* The subject is suitable for radial artery blood sampling and cannulation as demonstrated by the Allen test.
* Subject must be healthy as assessed using detailed medical history, laboratory tests, and physical examination.
* The subject must make use of contraception.

Exclusion Criteria

* The subject is left handed.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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UZ Leuven campus Gasthuisberg

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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18454A

Identifier Type: -

Identifier Source: org_study_id

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