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A Study to Evaluate LY3154207 on the Brain of Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04258826
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
12.4
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single-Dose Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of LY3154207 in Healthy Subjects
Actual Study Start Date :
Jan 15, 2021
Actual Primary Completion Date :
Jan 28, 2022
Actual Study Completion Date :
Jan 28, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Intrinsic Functional Connectivity Among Resting-State Networks of the Brain [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Chicago Illinois United States 60659

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04258826
Other Study ID Numbers:
  • 17294
  • I7S-MC-HBEM
First Posted:
Feb 6, 2020
Last Update Posted:
Feb 22, 2022
Last Verified:
Feb 15, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 22, 2022