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| ID | Type | Description | Link |
|---|---|---|---|
| I7S-EW-HBEB | Other Identifier | Eli Lilly and Company |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo matching LY3154207 administered once orally in one of four periods. |
|
| LY3154207 - Dose 1 | Experimental | LY3154207 administered orally in no more than one of the four periods. |
|
| LY3154207 - Dose 2 | Experimental | LY3154207 administered orally in no more than one of the four periods. |
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| LY3154207 - Dose 3 | Experimental | LY3154207 administered orally in no more than one of the four periods. |
|
| Modafinil | Active Comparator | 200 mg modafinil administered orally in no more than one of the four periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3154207 | Drug | LY3154207 administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Sleep Onset | Day 1: 2 hours post dose through 8 hours post dose in each period. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Early Phase Unit at Glendale | Glendale | California | 91206 | United States |
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| ID | Term |
|---|---|
| C000707472 | LY3154207 |
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | Placebo administered orally. |
|
| Modafinil | Drug | Modafinil administered orally. |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |