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| ID | Type | Description | Link |
|---|---|---|---|
| I2K-MC-ZZAA | Other Identifier | Eli Lilly and Company |
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The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy people. The study has four treatment periods. Participants will receive a single dose of LY2624803, another sleeping pill, or placebo in each treatment period. The study will last approximately 1 month for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3 mg LY2624803 | Experimental | Single dose of 0.3 mg LY2624803 administered orally in up to 2 of 4 treatment periods. |
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| 3.0 mg LY2624803 | Experimental | Single dose of 3.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods. |
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| 6.0 mg LY2624803 | Experimental | Single dose of 6.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods. |
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| 10 mg Zolpidem | Active Comparator | Single dose of 10 mg zolpidem administered orally in up to 1 of 4 treatment periods. |
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| Placebo | Placebo Comparator | Single dose of placebo administered orally in up to 1 of 4 treatment periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2624803 - Capsules | Drug | Administered orally as capsules. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo | Baseline up to Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Latency to Persistent Sleep (LPS) with LY2624803 Compared to Placebo | Baseline up to Day 60 | |
| Total Sleep Time (TST) with LY2624803 Compared to Placebo | Baseline up to Day 60 |
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rouffach |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Zolpidem - Tablets | Drug | Administered orally as tablets. |
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| Placebo - Capsules | Drug | Administered orally as capsules. |
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| Placebo - Tablets | Drug | Administered orally as tablets. |
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| France |
| D001523 |
| Mental Disorders |