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| ID | Type | Description | Link |
|---|---|---|---|
| I7T-MC-RMAA | Other Identifier | Eli Lilly and Company |
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This type of study is called a radiolabeled study. For this study, LY2623091 (study drug) has been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally occurring radioactive form of the element, carbon. This study will increase understanding about how the drug appears in the blood, urine, and stool after it is administered to healthy participants. Information about any side effects that may occur will also be collected. This study will last up to 22 days for each participant, not including screening. Screening is required within 28 days prior to enrollment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2623091 | Experimental | Single oral dose of LY2623091 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2623091 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals. | Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091 | Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours) | |
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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. | Madison | Wisconsin |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2623091 | Single dose of 25 milligrams (mg) LY2623091 containing carbon-14 [¹⁴C]-LY2623091 (approximately 100 microcuries [µCi]) administered orally. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2623091 | Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals. | All participants who received study drug and had quantifiable levels of radioactivity in urine and feces. | Posted | Mean | Standard Deviation | percentage of radioactive dose recovered | Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours) |
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Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
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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 | LY2623091 | Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | 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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| Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091 |
| Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours) |
| Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091 | Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours) |
| Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces | Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose |
| United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091 | All participants who received study drug and had evaluable AUC(0-tlast) values. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours) |
|
|
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| Secondary | Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091 | All participants who received study drug and had evaluable AUC(0-inf) values. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours) |
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|
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| Secondary | Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091 | All participants who received study drug and had evaluable Cmax values. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours) |
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|
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| Secondary | Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces | All participants who received study drug and had evaluable plasma, urine, and fecal samples. | Posted | Number | metabolites | Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose |
|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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