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

NCT ID: NCT03944031

Last Updated: 2020-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-08

Study Completion Date

2020-02-19

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3372689 + [18F]LSN3316612

LY3372689 administered orally followed by \[18F\]LSN3316612 PET tracer administered intravenously (IV) approximately 2 - 72 hours later.

Group Type EXPERIMENTAL

LY3372689

Intervention Type DRUG

Administered orally.

[18F]LSN3316612

Intervention Type DIAGNOSTIC_TEST

Administered IV.

Interventions

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LY3372689

Administered orally.

Intervention Type DRUG

[18F]LSN3316612

Administered IV.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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[18F]MNI-1068

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Invicro, Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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I9X-MC-MTAB

Identifier Type: OTHER

Identifier Source: secondary_id

17220

Identifier Type: -

Identifier Source: org_study_id

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