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

NCT ID: NCT04392271

Last Updated: 2020-11-04

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

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-06

Study Completion Date

2020-10-14

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 about 10 weeks. Screening must be completed within four weeks 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 24 hours later.

Group Type EXPERIMENTAL

LY3372689

Intervention Type DRUG

Administered orally.

[18F]LSN3316612

Intervention Type DIAGNOSTIC_TEST

Administered intravenously (IV).

Interventions

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LY3372689

Administered orally.

Intervention Type DRUG

[18F]LSN3316612

Administered intravenously (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 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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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-MTAD

Identifier Type: OTHER

Identifier Source: secondary_id

17243

Identifier Type: -

Identifier Source: org_study_id