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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392271
• Other study ID #: 17243
• Secondary ID: I9X-MC-MTAD
• Status: Completed
• Phase: Phase 1
• Start date: August 6, 2020
• Est. completion date: October 14, 2020

Study information

• Verified date: November 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 14, 2020
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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• Have previously participated or withdrawn from this study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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3372689
Administered orally.

Diagnostic Test:
• [18F]LSN3316612
Administered intravenously (IV).

Locations

Country	Name	City	State
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO)	Percent OGA EO	Approximately 2 to 96 hours following the first dose
Primary	Percent OGA EO	Percent OGA EO	Approximately 2 to 96 hours following the last dose
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of LY3372689	PK: AUC(0-tau) of LY3372689	Baseline through 24 hours
Secondary	PK: Maximum Concentration (Cmax) of LY3372689	PK: Cmax of LY3372689	Baseline through 24 hours