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OpenTrials
Completed

NCT Number: NCT03944031

A Study of the Effects 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 approximately 25 days after enrollment. Screening must be completed within 28 days prior to enrollment.

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Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Invicro, 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 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  • Have previously participated or withdrawn from this study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

Treatment and study plan

LY3372689

Drug

Administered orally.

[18F]LSN3316612

Diagnostic Test

Administered IV.

Other names: [18F]MNI-1068

Primary outcomes

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

    Time frame: Predose Scan (Days -14 to -1)

    Percent OGA EO

  2. Percent OGA EO

    Time frame: Postdose Scan 1 (Days 1 - 4)

    Percent OGA EO

  3. Percent OGA EO

    Time frame: Postdose Scan 2 (Days 2 - 4)

    Percent OGA EO

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 9, 2019
Registry last updated
Apr 22, 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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