NCT04419636

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started May 2020

Typical duration 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

May 29, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

June 3, 2020

Last Update Submit

February 23, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Central monoacylglycerol lipase (MAGL) occupancy

    From dosing to 8 hours post-dose

Secondary Outcomes (3)

  • C(PET)

    From zero to Day 10

  • AUC (0-24)

    From zero to 24 hours post-dose

  • Cmax

    From zero to 24 hours post-dose

Study Arms (2)

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

Lu AG06466DRUG

capsules, orally

Also known as: ABX-1431
Part A Single dosesPart B Repeated doses

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • The subject is left handed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven campus Gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

ABX-1431

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 5, 2020

Study Start

May 29, 2020

Primary Completion

February 9, 2021

Study Completion

February 16, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

BE(1)