Clinical trial NCT04392271: A Study of the Effects of Multiple Doses of LY3372689 on the Brain in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-05-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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* Have previously participated or withdrawn from this study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

Primary outcomes:
measure: Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO)
timeFrame: Approximately 2 to 96 hours following the first dose
measure: Percent OGA EO
timeFrame: Approximately 2 to 96 hours following the last dose
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of LY3372689
timeFrame: Baseline through 24 hours
measure: PK: Maximum Concentration (Cmax) of LY3372689
timeFrame: Baseline through 24 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: