A Study to Evaluate LY3154207 on the Brain of Healthy Participants

February 21, 2022 updated by: Eli Lilly and Company

A Single-Dose Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of LY3154207 in Healthy Subjects

The purpose of this study is to learn more about how LY3154207 affects the brain of healthy participants by using magnetic resonance imaging. The study will last up to about nine weeks for each participant and may include up to four visits to the study center.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60659
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Overtly healthy males and non-childbearing females, as determined through medical history and physical examination

Exclusion Criteria:

  • Have known or ongoing psychiatric disorders
  • Have contraindications to magnetic resonance imaging (MRI)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3154207
LY3154207 administered orally in one of two study periods.
Drug: LY3154207
LY3154207 administered orally.
Placebo Comparator: Placebo
Placebo administered orally in one of two study periods.
Drug: Placebo
Placebo administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Intrinsic Functional Connectivity Among Resting-State Networks of the Brain
Time Frame: Day 1, Approximately Day 28
Mean Connectivity and Mean Component Weight Between LY3154207 and Placebo in the Dorsal Attention Network (DAN), Frontoparietal Network (FPN), and Executive Control Network (ECN).
Day 1, Approximately Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

January 28, 2022

Study Completion (Actual)

January 28, 2022

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 15, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 17294
  • I7S-MC-HBEM (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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