A Study of LY3154207 on Sleep in Healthy Male Participants

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3154207
* Drug: Placebo
* Drug: Modafinil


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo matching LY3154207 administered once orally in one of four periods. | Drug: Placebo<br>* Placebo administered orally.<br>|
| Experimental: LY3154207 - Dose 1<br>LY3154207 administered orally in no more than one of the four periods. | Drug: LY3154207<br>* LY3154207 administered orally.<br>|
| Experimental: LY3154207 - Dose 2<br>LY3154207 administered orally in no more than one of the four periods. | Drug: LY3154207<br>* LY3154207 administered orally.<br>|
| Experimental: LY3154207 - Dose 3<br>LY3154207 administered orally in no more than one of the four periods. | Drug: LY3154207<br>* LY3154207 administered orally.<br>|
| Active Comparator: Modafinil<br>200 mg modafinil administered orally in no more than one of the four periods. | Drug: Modafinil<br>* Modafinil administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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