Binding of Lu AG06466 in the Brain in Healthy Men | NCT04419636

Studies
Binding of Lu AG06466 in the Brain in Healthy Men

NCT04419636

Sponsor

H. Lundbeck A/S

Status

Completed

Last Update Posted

Feb 24, 2021Actual

Enrollment

16Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Lu AG06466

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2020Actual

Primary Completion Date

Feb 9, 2021Actual

Completion Date

Feb 16, 2021Actual

First Submitted Date

Jun 3, 2020

First Submission Date that Met QC Criteria

Jun 3, 2020

First Posted Date

Jun 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2021

Last Update Posted Date

Feb 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part A Single doses	Experimental	Lu AG06466 in fast and fed state	Drug: Lu AG06466
Part B Repeated doses	Experimental	Lu AG06466 after light meal	Drug: Lu AG06466

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lu AG06466	Drug	capsules, orally	Part A Single doses Part B Repeated doses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Central monoacylglycerol lipase (MAGL) occupancy		From dosing to 8 hours post-dose

Secondary Outcomes

Measure	Description	Time Frame
C(PET)	Average plasma concentration for Lu AG06466 and Lu AG06988 during PET imaging	From zero to Day 10
AUC (0-24)	Area under the plasma concentration curve for Lu AG06466 and Lu AG06988 from zero to 24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Other in- and exclusion criteria may apply

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Email contact via H. Lundbeck A/S	LundbeckClinicalTrials@Lundbeck.com	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven campus Gasthuisberg		Leuven		3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000634455	ABX-1431

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided