A Study of LY3154207 on Sleep in Healthy Male Participants

April 4, 2016 updated by: Eli Lilly and Company

An Evaluation of the Impact of Single Doses of LY3154207 on Sleep Latency in Sleep-Deprived Healthy Subjects

This study will evaluate the effect of single doses of LY3154207 on the amount of time it takes for healthy sleep-deprived men to fall asleep. The study will also estimate how much LY3154207 gets into the blood stream and how long it takes the body to remove it. Information about any side effects that occur will be collected. Each participant will complete four study periods, which will last a total of about 8 weeks.

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
    • California
      • Glendale, California, United States, 91206
        • Parexel Early Phase Unit at Glendale

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Overtly healthy males 18 years of age or older who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
  • Have a regular sleep pattern with routine time spent in bed between 6.5 hours and 9 hours each night

Exclusion Criteria:

  • Are shift workers who shifted work within 14 days prior to screening or plan to during the study
  • Have a known sleep disorder or history of a sleep disorder
  • Have traveled 2 time zones or more within 7 days prior to screening or plan to during the study
  • Regularly take naps during the day
  • Are hearing impaired

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
Placebo Comparator: Placebo
Placebo matching LY3154207 administered once orally in one of four periods.
Drug: Placebo
Placebo administered orally.
Experimental: LY3154207 - Dose 1
LY3154207 administered orally in no more than one of the four periods.
Drug: LY3154207
LY3154207 administered orally.
Experimental: LY3154207 - Dose 2
LY3154207 administered orally in no more than one of the four periods.
Drug: LY3154207
LY3154207 administered orally.
Experimental: LY3154207 - Dose 3
LY3154207 administered orally in no more than one of the four periods.
Drug: LY3154207
LY3154207 administered orally.
Active Comparator: Modafinil
200 mg modafinil administered orally in no more than one of the four periods.
Drug: Modafinil
Modafinil administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Sleep Onset
Time Frame: Day 1: 2 hours post dose through 8 hours post dose in each period.
Day 1: 2 hours post dose through 8 hours post dose in each period.

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum Concentration (Cmax) of LY3154207
Time Frame: Day 1: 1 hour post dose through 24 hours post dose in each period.
Day 1: 1 hour post dose through 24 hours post dose in each period.
Area Under the Concentration Versus Time Curve (AUC) of LY3154207
Time Frame: Day 1: 1 hour post dose through 24 hours post dose in each period.
Day 1: 1 hour post dose through 24 hours post dose in each period.

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

November 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 11, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15511
  • I7S-EW-HBEB (Other Identifier: Eli Lilly and Company)

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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