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A Study of the Effects of Multiple Doses of LY3372689 on the Brain in Healthy Participants

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04392271
Enrollment
4
Registered
2020-05-18
Start date
2020-08-06
Completion date
2020-10-14
Last updated
2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

Administered orally.

DIAGNOSTIC_TEST[18F]LSN3316612

Administered intravenously (IV).

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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days or any other type of medical research judged to be incompatible with this study * Have previously participated or withdrawn from this study * Have had prior participation in other research protocols or clinical care in the preceding year in addition to the radiation exposure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

Design outcomes

Primary

MeasureTime frameDescription
Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO)Approximately 2 to 96 hours following the first dosePercent OGA EO
Percent OGA EOApproximately 2 to 96 hours following the last dosePercent OGA EO

Secondary

MeasureTime frameDescription
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of LY3372689Baseline through 24 hoursPK: AUC(0-tau) of LY3372689
PK: Maximum Concentration (Cmax) of LY3372689Baseline through 24 hoursPK: Cmax of LY3372689

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026