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Completed

NCT Number: NCT02603861

A Study of LY3154207 on Sleep in Healthy Male Participants

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Parexel Early Phase Unit at Glendale

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3154207

Drug

LY3154207 administered orally.

Placebo

Drug

Placebo administered orally.

Modafinil

Drug

Modafinil administered orally.

Primary outcomes

  1. Time to Sleep Onset

    Time frame: Day 1: 2 hours post dose through 8 hours post dose in each period.

Secondary outcomes

  1. Maximum Concentration (Cmax) of LY3154207

    Time frame: Day 1: 1 hour post dose through 24 hours post dose in each period.

  2. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 13, 2015
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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