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

NCT04392271 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17243I9X-MC-MTAD
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO)

  Percent OGA EO

  Approximately 2 to 96 hours following the first dose

• Percent OGA EO

  Percent OGA EO

  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

  Baseline through 24 hours

• PK: Maximum Concentration (Cmax) of LY3372689

  Baseline through 24 hours

Study Arms (1)

LY3372689 + [18F]LSN3316612

EXPERIMENTAL

LY3372689 administered orally followed by \[18F\]LSN3316612 PET tracer administered intravenously (IV) approximately 24 hours later.

Drug: LY3372689; Diagnostic Test: [18F]LSN3316612

Interventions

LY3372689 DRUG

Administered orally.

LY3372689 + [18F]LSN3316612

[18F]LSN3316612 DIAGNOSTIC_TEST

Administered intravenously (IV).

Also known as: [18F]MNI-1068

LY3372689 + [18F]LSN3316612

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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• Have previously participated or withdrawn from this study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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 18, 2020
• Study Start: August 6, 2020
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)