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| ID | Type | Description | Link |
|---|---|---|---|
| I5U-MC-ANBB | Other Identifier | Eli Lilly and Company |
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The purposes of this study are to determine the safety and side effects of LY3000328, to determine how well the body will tolerate LY3000328, and to determine how long LY3000328 remains in the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single dose of placebo administered orally in 1 out of 3 study periods separated by at least a 7-day wash-out period between each dose. |
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| LY3000328 | Experimental | Single escalating dose of up to 300 mg/kg of LY3000328 administered orally in 2 out of 3 study periods separated by at least a 7 day wash-out period between each dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered orally |
| |
| LY3000328 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with one or more drug related adverse events (AEs) or any serious AEs | Baseline to study completion (estimate 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328 | Pre-dose up to Day 6 post-dose | |
| Pharmacokinetics: Maximum concentration (Cmax) of LY3000328 | Pre-dose up to Day 6 post-dose |
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Inclusion 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. | Singapore | 117597 |
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| ID | Term |
|---|---|
| C000601502 | LY3000328 |
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| Drug |
Administered orally |
|
| Change in Cathepsin S (CatS) activity | Pre-dose, up to 48 hours post-dose |
| Singapore |