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| ID | Type | Description | Link |
|---|---|---|---|
| I1R-MC-GLDL | Other Identifier | Eli Lilly and Company |
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The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is to determine how much LY2409021 enters the bloodstream and how long the body takes to get rid of the drug after the dose. This study will last approximately 28 days, not including screening. Screening can occur within 30 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2409021 | Experimental | Single oral dose of 20 milligrams (mg) LY2409021. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2409021 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021 | Area under the concentration versus time curve from zero to infinity (AUC[0-inf]) of LY2409021 is presented. | Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose | |
| Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021 | Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
- Abnormal electrocardiograms (ECGs)
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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. | Daytona Beach | Florida |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2409021 | Single oral dose of 20 milligrams (mg) LY2409021. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2409021 | Single oral dose of 20 mg LY2409021. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021 | Area under the concentration versus time curve from zero to infinity (AUC[0-inf]) of LY2409021 is presented. | All participants who received a dose of study drug and had evaluable AUC(0-inf) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hours per milliliter (ng*h/mL) | Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LY2409021 | Single oral dose of 20 mg LY2409021. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| C000601762 | adomeglivant |
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| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | All participants who received a dose of study drug and had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose |
|
|
|
| Primary | Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021 | All participants who received a dose of study drug and had evaluable Tmax data. | Posted | Median | Full Range | hours | Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose |
|
|
|
| 0 |
| 16 |
| 3 |
| 16 |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
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