- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04419636
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
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:
|
EXPERIMENTAL: Part B Repeated doses
Lu AG06466 after light meal
|
capsules, orally
Other Names:
|
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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