HealthyPhase 1NCT04419636
Binding of Lu AG06466 in the Brain in Healthy Men
A Phase 1 study testing Lu AG06466 in people with Healthy, run by H. Lundbeck A/S at 1 site in Belgium.
Trial summary
A study to learn how Lu AG06466 and one of its break down products binds in the brain after single and repeated dosing Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lu AG06466
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 29 May 2020to 16 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- The subject is left handed.
- Other in- and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Healthy
- Being tested
- Lu AG06466
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AG06466Drug
Also called ABX-1431
capsules, orally
| Study group | Role | What they receive |
|---|---|---|
| Part A Single doses | Experimental | Lu AG06466 in fast and fed state Receives: Drug: Lu AG06466 |
| Part B Repeated doses | Experimental | Lu AG06466 after light meal Receives: Drug: Lu AG06466 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central monoacylglycerol lipase (MAGL) occupancy
Measured: From dosing to 8 hours post-dose
Secondary outcomes (3)
C(PET)
Average plasma concentration for Lu AG06466 and Lu AG06988 during PET imaging
Measured: 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
Measured: From zero to 24 hours post-dose
Cmax
Maximum observed plasma concentration for Lu AG06466 and Lu AG06988
Measured: From zero to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start29 May 2020
- Primary completion9 Feb 2021
- Study completion16 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419636
- Sponsor's protocol ID
- 18454A
- Status last verified
- Feb 2021
- First submitted
- 3 Jun 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Position Emission Tomography (PET) Study Investigating MAGL Occupancy After Single and Multiple Oral Doses of Lu AG06466 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04419636
- Acronym / sponsor ID
- 18454A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 29 May 2020 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A Single doses | Experimental | Drug: Lu AG06466Lu AG06466 in fast and fed state |
| Part B Repeated doses | Experimental | Drug: Lu AG06466Lu AG06466 after light meal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- The subject is left handed.
- Other in- and exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AG06466Also: ABX-1431capsules, orally | Drug | Part A Single doses, Part B Repeated doses |
Primary outcome
Central monoacylglycerol lipase (MAGL) occupancy
Time frame: From dosing to 8 hours post-dose
3 secondary outcomes
C(PET)
Time frame: From zero to Day 10
AUC (0-24)
Time frame: From zero to 24 hours post-dose
Cmax
Time frame: From zero to 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu AG06466 in people with Healthy, run by H. Lundbeck A/S at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central monoacylglycerol lipase (MAGL) occupancy (time frame: From dosing to 8 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.