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| ID | Type | Description | Link |
|---|---|---|---|
| I6S-MC-ASEA | Other Identifier | Eli Lilly and Company | |
| 2012-004968-22 | EudraCT Number |
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The purpose of this study is to investigate the safety and tolerability of LY3045697 after a single dose, and to determine how long LY3045697 remains in the body. Two cohorts (groups) of 9 participants each will participate in 3 dosing periods. These participants will receive placebo in one period only. A third cohort of 9 will participate in 2 dosing periods and participants will receive either 2 dose levels of LY3045697 or 1 dose level of LY3045697 and placebo by the end of both periods.
Cohort 3 added per protocol amendment (April, 2013).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Period 1: 0.1 milligrams (mg) LY3045697 administered once orally or matching placebo administered once orally. Period 2: 1 mg LY3045697 administered once orally or matching placebo administered once orally. Period 3: 10 mg LY3045697 administered once orally or matching placebo administered once orally. |
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| Group 2 | Experimental | Period 1: 0.3 mg LY3045697 administered once orally or matching placebo administered once orally. Period 2: 3 mg LY3045697 administered once orally or matching placebo administered once orally. Period 3: 30 mg LY3045697 administered once orally or matching placebo administered once orally. |
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| Group 3 | Experimental | Period 1: 100 mg of LY3045697 administered once orally or matching placebo administered once orally. Period 2: 300 mg of LY3045697 administered once orally or matching placebo administered once orally (via split delivery over a 15-minute period). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3045697 | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Clinically Significant Adverse Events (AEs) or Any Serious AEs | Baseline to 10 Days Post Dose (Estimated up to 8 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3045697 | Baseline to 72 Hours Post Dose | |
| Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) from Zero to Infinity (AUC 0-∞) of LY3045697 | Baseline to 72 Hours Post Dose |
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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. | Zuidlaren |
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| Placebo |
| Drug |
Administered orally |
|
| Netherlands |