Binding of Lu AG06466 in the Brain in Healthy Men

February 23, 2021 updated by: H. Lundbeck A/S

Interventional, Open-label, Position Emission Tomography (PET) Study Investigating MAGL Occupancy After Single and Multiple Oral Doses of Lu AG06466 in Healthy Male Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leuven, Belgium, 3000
        • UZ Leuven campus Gasthuisberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Part A Single doses
Lu AG06466 in fast and fed state
capsules, orally
Other Names:
  • ABX-1431
EXPERIMENTAL: Part B Repeated doses
Lu AG06466 after light meal
capsules, orally
Other Names:
  • ABX-1431

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 29, 2020

Primary Completion (ACTUAL)

February 9, 2021

Study Completion (ACTUAL)

February 16, 2021

Study Registration Dates

First Submitted

June 3, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (ACTUAL)

June 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 18454A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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