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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03944031

Recruitment Status Completed

First Posted May 9, 2019

Last update posted April 22, 2020

Study Description

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 approximately 25 days after enrollment. Screening must be completed within 28 days prior to enrollment.

  • Condition or Disease:Healthy
  • Intervention/Treatment: Drug: LY3372689
    Diagnostic Test: [18F]LSN3316612
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 17 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Basic Science
  • 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
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: February 2020
  • Actual Study Completion Date: February 2020
Arms and interventions
Arm Intervention/treatment
Experimental: LY3372689 + [18F]LSN3316612
LY3372689 administered orally followed by [18F]LSN3316612 PET tracer administered intravenously (IV) approximately 2 - 72 hours later.
Drug: LY3372689
Administered orally.

Diagnostic Test: [18F]LSN3316612
Administered IV.
Outcome Measures
  • Primary Outcome Measures: 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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts
Locations

United States, Connecticut
Invicro, Institute for Neurodegenerative Disorders
New Haven

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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

More Information
  • Responsible Party: Eli Lilly and Company
  • ClinicalTrials.gov Identifier: NCT03944031 History of Changes
  • Other Study ID Numbers: 17220, I9X-MC-MTAB
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: April 22, 2020
  • Last Verified: April 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes