HealthyPhase 1NCT03944031
A Study of the Effects of LY3372689 on the Brain in Healthy Participants
A Phase 1 study testing LY3372689 and [18F]LSN3316612 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This study uses imaging to evaluate how LY3372689 binds to a protein in the brain. This study will be conducted in healthy participants and will last up to approximately 25 days after enrollment. Screening must be completed within 28 days prior to enrollment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3372689 and [18F]LSN3316612
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2019to 19 Feb 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overtly healthy males or females who cannot get pregnant
- Have a body mass index (BMI) of at least 18.5 kilogram per square meter (kg/m²), inclusive, at screening
- Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
- Have veins and arteries suitable for protocol required blood sampling
Who cannot join
- Have a history of head injury or contraindications to undergoing magnetic resonance imaging (MRI) examination
- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- Have previously participated or withdrawn from this study
- Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure
- Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
- Have long exposure to sunlight routinely or use tanning beds regularly
- Participate in regular vigorous exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Invicro, Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
About this study
Official title: Assessment of Brain O-GlcNAcase (OGA) Enzyme Occupancy After Single Oral Doses of LY3372689 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]LSN3316612 in Healthy Subjects
This study uses imaging to evaluate how LY3372689 binds to a protein in the brain. This study will be conducted in healthy participants and will last up to approximately 25 days after enrollment. Screening must be completed within 28 days prior to enrollment.
- Conditions
- Healthy
- Being tested
- LY3372689, [18F]LSN3316612
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3372689Drug
Administered orally.
[18F]LSN3316612Diagnostic test
Also called [18F]MNI-1068
Administered IV.
| Study group | Role | What they receive |
|---|---|---|
| LY3372689 + [18F]LSN3316612 | Experimental | LY3372689 administered orally followed by [18F]LSN3316612 PET tracer administered intravenously (IV) approximately 2 - 72 hours later. Receives: Drug: LY3372689; Diagnostic Test: [18F]LSN3316612 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO)
Percent OGA EO
Measured: Predose Scan (Days -14 to -1)
Percent OGA EO
Percent OGA EO
Measured: Postdose Scan 1 (Days 1 - 4)
Percent OGA EO
Percent OGA EO
Measured: Postdose Scan 2 (Days 2 - 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start8 May 2019
- Primary completion19 Feb 2020
- Study completion19 Feb 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 Eli Lilly and CompanyThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944031
- Sponsor's protocol ID
- 17220
- Other IDs
- I9X-MC-MTAB
- Status last verified
- 15 Apr 2020
- First submitted
- 2 May 2019
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Brain O-GlcNAcase (OGA) Enzyme Occupancy After Single Oral Doses of LY3372689 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]LSN3316612 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03944031
- Acronym / sponsor ID
- 17220
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 8 May 2019 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 9 May 2019 (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 uses imaging to evaluate how LY3372689 binds to a protein in the brain. This study will be conducted in healthy participants and will last up to approximately 25 days after enrollment. Screening must be completed within 28 days prior to enrollment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY3372689 + [18F]LSN3316612 | Experimental | Drug: LY3372689, Diagnostic Test: [18F]LSN3316612LY3372689 administered orally followed by [18F]LSN3316612 PET tracer administered intravenously (IV) approximately 2 - 72 hours later. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Overtly healthy males or females who cannot get pregnant
- Have a body mass index (BMI) of at least 18.5 kilogram per square meter (kg/m²), inclusive, at screening
- Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
- Have veins and arteries suitable for protocol required blood sampling
Key exclusion criteria (7 listed)
- Have a history of head injury or contraindications to undergoing magnetic resonance imaging (MRI) examination
- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- Have previously participated or withdrawn from this study
- Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure
- Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
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 |
|---|---|---|
| LY3372689Administered orally. | Drug | LY3372689 + [18F]LSN3316612 |
| [18F]LSN3316612Also: [18F]MNI-1068Administered IV. | Diagnostic test | LY3372689 + [18F]LSN3316612 |
Primary outcome
Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO)
Time frame: Predose Scan (Days -14 to -1)
Percent OGA EO
Percent OGA EO
Time frame: Postdose Scan 1 (Days 1 - 4)
Percent OGA EO
Percent OGA EO
Time frame: Postdose Scan 2 (Days 2 - 4)
Percent OGA EO
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 22 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
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 LY3372689 and [18F]LSN3316612 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
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 4 inclusion and 7 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 22 Apr 2020. 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 States. 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?
Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO) (time frame: Predose Scan (Days -14 to -1)). The study lists 3 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 22 Apr 2020.