A Study of LY3154207 on Sleep in Healthy Male Participants

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo matching LY3154207 administered once orally in one of four periods.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered orally.

LY3154207 - Dose 1

LY3154207 administered orally in no more than one of the four periods.

Group Type EXPERIMENTAL

LY3154207

Intervention Type DRUG

LY3154207 administered orally.

LY3154207 - Dose 2

LY3154207 administered orally in no more than one of the four periods.

Group Type EXPERIMENTAL

LY3154207

Intervention Type DRUG

LY3154207 administered orally.

LY3154207 - Dose 3

LY3154207 administered orally in no more than one of the four periods.

Group Type EXPERIMENTAL

LY3154207

Intervention Type DRUG

LY3154207 administered orally.

Modafinil

200 mg modafinil administered orally in no more than one of the four periods.

Group Type ACTIVE_COMPARATOR

Modafinil

Intervention Type DRUG

Modafinil administered orally.

Interventions

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LY3154207

LY3154207 administered orally.

Intervention Type DRUG

Placebo

Placebo administered orally.

Intervention Type DRUG

Modafinil

Modafinil administered orally.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes