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OpenTrials
Completed

NCT Number: NCT04392271

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously participated or withdrawn from this study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

Treatment and study plan

LY3372689

Drug

Administered orally.

[18F]LSN3316612

Diagnostic Test

Administered intravenously (IV).

Other names: [18F]MNI-1068

Primary outcomes

  1. Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO)

    Time frame: Approximately 2 to 96 hours following the first dose

    Percent OGA EO

  2. Percent OGA EO

    Time frame: Approximately 2 to 96 hours following the last dose

    Percent OGA EO

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of LY3372689

    Time frame: Baseline through 24 hours

    PK: AUC(0-tau) of LY3372689

  2. PK: Maximum Concentration (Cmax) of LY3372689

    Time frame: Baseline through 24 hours

    PK: Cmax of LY3372689

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 18, 2020
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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