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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03944031
• Other study ID #: 17220
• Secondary ID: I9X-MC-MTAB
• Status: Completed
• Phase: Phase 1
• Start date: May 8, 2019
• Est. completion date: February 19, 2020

Study information

• Verified date: April 15, 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 approximately 25 days after enrollment. Screening must be completed within 28 days prior to enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 19, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

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• Have previously participated or withdrawn from this study

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3372689
Administered orally.

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

Locations

Country	Name	City	State
United States	Invicro, 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	Predose Scan (Days -14 to -1)
Primary	Percent OGA EO	Percent OGA EO	Postdose Scan 1 (Days 1 - 4)
Primary	Percent OGA EO	Percent OGA EO	Postdose Scan 2 (Days 2 - 4)