HealthyPhase 1NCT04392271
A Study of the Effects of Multiple Doses 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 about 10 weeks. Screening must be completed within four weeks prior to enrollment. Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2020to 14 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overtly healthy males or females who do not have child-bearing potential
- Have a body mass index (BMI) of greater than (>)18 to less than or equal to (≤32) kilograms 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 venous access sufficient to allow for 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- Have previously participated or withdrawn from this study
- Have had prior participation in other research protocols or clinical care in the preceding year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 milliSievert (mSv), which would be above the acceptable annual limit established by the US Federal Guidelines
- Are current smokers or have used tobacco or nicotine-containing products as determined by the cotinine test
- 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
- Participate in regular vigorous exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
About this study
Official title: Assessment of Brain O-GlcNAcase (OGA) Enzyme Occupancy After Multiple Oral Doses of LY3372689 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]LY3316612 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 about 10 weeks. Screening must be completed within four weeks 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 intravenously (IV).
| Study group | Role | What they receive |
|---|---|---|
| LY3372689 + [18F]LSN3316612 | Experimental | LY3372689 administered orally followed by [18F]LSN3316612 PET tracer administered intravenously (IV) approximately 24 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: Approximately 2 to 96 hours following the first dose
Percent OGA EO
Percent OGA EO
Measured: Approximately 2 to 96 hours following the last dose
Secondary outcomes (2)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of LY3372689
PK: AUC(0-tau) of LY3372689
Measured: Baseline through 24 hours
PK: Maximum Concentration (Cmax) of LY3372689
PK: Cmax of LY3372689
Measured: Baseline through 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start6 Aug 2020
- Primary completion14 Oct 2020
- Study completion14 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 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
- 4 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
- NCT04392271
- Sponsor's protocol ID
- 17243
- Other IDs
- I9X-MC-MTAD
- Status last verified
- Nov 2020
- First submitted
- 21 Apr 2020
- Last updated
- 4 Nov 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 4 Nov 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 Multiple Oral Doses of LY3372689 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]LY3316612 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04392271
- Acronym / sponsor ID
- 17243
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 18 May 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 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 about 10 weeks. Screening must be completed within four weeks 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 24 hours later. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Overtly healthy males or females who do not have child-bearing potential
- Have a body mass index (BMI) of greater than (>)18 to less than or equal to (≤32) kilograms 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 venous access sufficient to allow for 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
- Have had prior participation in other research protocols or clinical care in the preceding year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 milliSievert (mSv), which would be above the acceptable annual limit established by the US Federal Guidelines
- Are current smokers or have used tobacco or nicotine-containing products as determined by the cotinine test
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 intravenously (IV). | Diagnostic test | LY3372689 + [18F]LSN3316612 |
Primary outcome
Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO)
Time frame: Approximately 2 to 96 hours following the first dose
Percent OGA EO
Percent OGA EO
Time frame: Approximately 2 to 96 hours following the last dose
Percent OGA EO
2 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of LY3372689
Time frame: Baseline through 24 hours
PK: Maximum Concentration (Cmax) of LY3372689
Time frame: Baseline through 24 hours
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 4 Nov 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 4 Nov 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: Approximately 2 to 96 hours following the first dose). The study lists 2 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 4 Nov 2020.