HealthyPhase 1NCT04538014
A Study in Healthy Men to Investigate Uptake and Distribution of Lu AF88434 in the Brain
A Phase 1 study testing Lu AF88434 and [11C]-Lu AF88434 in people with Healthy, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
This study will investigate how much of Lu AF88434 will get into the blood and the brain in healthy men Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lu AF88434 and [11C]-Lu AF88434
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Aug 2020to 21 Oct 2020
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit
- The subject has a normal MRI performed during the screening period, as judged by the investigator
- The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests
- The subject can tolerate confined spaces for prolonged periods of time
- The subject is suitable for radial artery blood sampling and cannulation
Who cannot join
- The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the Investigational Medicinal Product (IMP)
- Other in- or exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Parexel International Northwick Park Hospital (Level 7)
Middlesex, HA1 3UJ
About this study
Official title: Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-Lu AF88434 Investigating Blood-brain Barrier Penetration, Safety, and Tolerability of Lu AF88434 in Healthy Men
This study will investigate how much of Lu AF88434 will get into the blood and the brain in healthy men
Read the detailed description
The study consists of the following parts:
- a Screening Visit
- an MRI scanning visit
- an in-clinic stay which includes: a Safety Baseline one day prior to dosing, a one-day [11C]-Lu AF88434 imaging session consisting of a baseline PET measurement and a post-dose PET measurement conducted after the administration of a single oral dose of Lu AF88434, pharmacokinetic (PK) sampling and safety assessments throughout the period
- a Follow-up Visit 7 days after dosing
- Conditions
- Healthy
- Being tested
- Lu AF88434, [11C]-Lu AF88434
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF88434Drug
Oral solution
[11C]-Lu AF88434Drug
[11C]-Lu AF88434, and a radioactive dose not exceeding 400 MBq at each PET examination, intravenous bolus injection
| Study group | Role | What they receive |
|---|---|---|
| Lu AF88434 | Experimental | Not described Receives: Drug: Lu AF88434; Drug: [11C]-Lu AF88434 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total distribution volume (VT) of [11C]-Lu AF88434
Whole-brain distribution volume
Measured: At baseline and post-dose on Day 1
C(PET) of Lu AF88434
Mean plasma concentration of Lu AF88434 during the post-dose PET measurement
Measured: Day 1
Area Under Curve (AUC(0-inf)) of Lu AF88434
Area under the plasma concentration time curve of Lu AF88434 from zero to infinity
Measured: Day 1
Cmax of Lu AF88434
Maximum observed plasma concentration of Lu AF88434
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start24 Aug 2020
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT04538014
- Sponsor's protocol ID
- 18426A
- Status last verified
- Feb 2021
- First submitted
- 25 Aug 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, Positron Emission Tomography (PET) Study With [11C]-Lu AF88434 Investigating Blood-brain Barrier Penetration, Safety, and Tolerability of Lu AF88434 in Healthy Men
- ClinicalTrials.gov ID
- NCT04538014
- Acronym / sponsor ID
- 18426A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 3 Sep 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.
This study will investigate how much of Lu AF88434 will get into the blood and the brain in healthy men
Detailed description
The study consists of the following parts:
- a Screening Visit
- an MRI scanning visit
- an in-clinic stay which includes: a Safety Baseline one day prior to dosing, a one-day [11C]-Lu AF88434 imaging session consisting of a baseline PET measurement and a post-dose PET measurement conducted after the administration of a single oral dose of Lu AF88434, pharmacokinetic (PK) sampling and safety assessments throughout the period
- a Follow-up Visit 7 days after dosing
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu AF88434 | Experimental | Drug: Lu AF88434, Drug: [11C]-Lu AF88434 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit
- The subject has a normal MRI performed during the screening period, as judged by the investigator
- The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests
- The subject can tolerate confined spaces for prolonged periods of time
- The subject is suitable for radial artery blood sampling and cannulation
Key exclusion criteria (2 listed)
- The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the Investigational Medicinal Product (IMP)
- Other in- or 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 AF88434Oral solution | Drug | Lu AF88434 |
| [11C]-Lu AF88434[11C]-Lu AF88434, and a radioactive dose not exceeding 400 MBq at each PET examination, intravenous bolus injection | Drug | Lu AF88434 |
Primary outcome
Total distribution volume (VT) of [11C]-Lu AF88434
Time frame: At baseline and post-dose on Day 1
Whole-brain distribution volume
C(PET) of Lu AF88434
Time frame: Day 1
Mean plasma concentration of Lu AF88434 during the post-dose PET measurement
Area Under Curve (AUC(0-inf)) of Lu AF88434
Time frame: Day 1
Area under the plasma concentration time curve of Lu AF88434 from zero to infinity
Cmax of Lu AF88434
Time frame: Day 1
Maximum observed plasma concentration of Lu AF88434
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 AF88434 and [11C]-Lu AF88434 in people with Healthy, run by H. Lundbeck A/S at 1 site in United Kingdom.
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 5 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 United Kingdom. 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?
Total distribution volume (VT) of [11C]-Lu AF88434 (time frame: At baseline and post-dose on Day 1). The study lists 4 primary outcomes in all. 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.