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| ID | Type | Description | Link |
|---|---|---|---|
| I4J-MC-HHBF | Other Identifier | Eli Lilly and Company |
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This is a single dose study of radiolabelled LY2940680 taken by mouth in healthy participants to study how the body absorbs and removes LY2940680 from the blood. This study is for research purposes only and is not intended to treat any medical condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [^14C]-LY2940680 | Experimental | Single 100 milligram (mg) dose of LY2940680 containing 100 microCuries of carbon-14-labeled LY2940680 ([^14C]-LY2940680) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [^14C]-LY2940680 | Drug | Administered as solution by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | The percentage of the total radioactive dose administered that was excreted in feces = [(amount of radioactivity recovered in feces)/(radioactive dose administered)]*100. | Predose up to 14 days postdose. Samples collected at 24-h intervals. |
| Urinary Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | The percentage of the total radioactive dose administered that was excreted in urine=[(amount of radioactivity recovered in urine)/(radioactive dose administered)]*100. | Predose up to 14 days postdose. Samples collected at 6-h intervals on Day 1 (0-6, 6-12, and 12-24 h postdose) and at 24-h intervals thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PK of LY2940680 and LSN3185556: Maximum Observed Concentration (Cmax) | The Cmax of LY2940680 and its equipotent active metabolite in the free base form, LSN3185556, is reported. | Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter |
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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 | 53704 |
Participants completed study at 14 days postdose or earlier if ≥90% of administered radioactivity recovered or 24-hour (h) urine and fecal samples from 2 consecutive collections each had radioactivity levels <1.0% of total administered radioactivity in urine and feces combined.
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| ID | Title | Description |
|---|---|---|
| FG000 | [^14C]-LY2940680 | Single 100-milligram (mg) LY2940680 dose containing 100 microCuries of carbon-14-labeled LY2940680 ([^14C]-LY2940680), administered as an oral solution. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Enrolled participants who received study drug and had at least 1 safety assessment postdose.
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| ID | Title | Description |
|---|---|---|
| BG000 | [^14C]-LY2940680 | Single 100-mg LY2940680 dose containing 100 microCuries of [^14C]-LY2940680, administered as an oral solution. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Fecal Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | The percentage of the total radioactive dose administered that was excreted in feces = [(amount of radioactivity recovered in feces)/(radioactive dose administered)]*100. | Enrolled participants who received study drug and had evaluable pharmacokinetic (PK) data. | Posted | Mean | Standard Deviation | percentage of dose administered | Predose up to 14 days postdose. Samples collected at 24-h intervals. |
|
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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 | [^14C]-LY2940680 | Single 100-mg LY2940680 dose containing 100 microCuries of [^14C]-LY2940680, administered as an oral solution. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| PK of Radioactivity: Cmax |
| Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter. |
| PK of LY2940680, LSN3185556, and Radioactivity: Time of Maximum Observed Concentration (Tmax) | The Tmax of LY2940680, LSN3185556, and total radioactivity in plasma are reported, as well as the Tmax for total radioactivity in whole blood. | Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter. |
| Plasma PK of LY2940680 and LSN3185556: Area Under the Concentration-Time Curve From Time 0 to the Last Time Point With a Measurable Concentration [AUC(0 to Tlast)] | Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter. |
| PK of Radioactivity: AUC(0 to Tlast) | AUC(0 to Tlast) of total radioactivity in plasma and whole blood are reported in nanograms*hour equivalents per gram (ng*h Eq/g). | Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter. |
| Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Plasma | Relative abundance was expressed and calculated as the percentage of plasma sample radioactivity=[(radioactivity in peak)/(radioactivity in sample)]*100. Metabolites with a relative abundance ≤6% are not reported. | Day 1 up to 3 days postdose. Samples collected at 2, 3, 4, 6, and 8 h postdose on Day 1 and every 24 h thereafter. |
| Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Urine | Relative abundance was expressed and calculated as the percentage of administered dose excreted in urine=[(percentage of radioactivity in peak)/100]*(percentage of dose in sample). Metabolites with a relative abundance ≤1% are not reported. | Predose up to 4 days postdose. Samples collected at 6-h intervals on Day 1 (0-6, 6-12, and 12-24 h postdose) and at 24-h intervals thereafter. |
| Relative Abundance of LY2940680, the Metabolites of LY2940680, and LSN3185556 in Feces | Relative abundance was expressed and calculated as the percentage of the administered dose excreted in feces=[(percentage of radioactivity in peak)/100]*(percentage of dose in sample). Metabolites with a relative abundance ≤1% are not reported. | Predose up to 8 days postdose. Samples collected at 24-h intervals. |
| United States |
| Participants |
| No |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Urinary Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | The percentage of the total radioactive dose administered that was excreted in urine=[(amount of radioactivity recovered in urine)/(radioactive dose administered)]*100. | Enrolled participants who received study drug and had evaluable PK data. | Posted | Mean | Standard Deviation | percentage of dose administered | Predose up to 14 days postdose. Samples collected at 6-h intervals on Day 1 (0-6, 6-12, and 12-24 h postdose) and at 24-h intervals thereafter. |
|
|
|
| Secondary | Plasma PK of LY2940680 and LSN3185556: Maximum Observed Concentration (Cmax) | The Cmax of LY2940680 and its equipotent active metabolite in the free base form, LSN3185556, is reported. | Enrolled participants who received study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter |
|
|
|
| Secondary | PK of Radioactivity: Cmax | Enrolled participants who received study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalents per gram (ng Eq/g) | Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter. |
|
|
|
| Secondary | PK of LY2940680, LSN3185556, and Radioactivity: Time of Maximum Observed Concentration (Tmax) | The Tmax of LY2940680, LSN3185556, and total radioactivity in plasma are reported, as well as the Tmax for total radioactivity in whole blood. | Enrolled participants who received study drug and had evaluable PK data. | Posted | Median | Full Range | h | Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter. |
|
|
|
| Secondary | Plasma PK of LY2940680 and LSN3185556: Area Under the Concentration-Time Curve From Time 0 to the Last Time Point With a Measurable Concentration [AUC(0 to Tlast)] | Enrolled participants who received study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*h/mL) | Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter. |
|
|
|
| Secondary | PK of Radioactivity: AUC(0 to Tlast) | AUC(0 to Tlast) of total radioactivity in plasma and whole blood are reported in nanograms*hour equivalents per gram (ng*h Eq/g). | Enrolled participants who received study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h Eq/g | Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter. |
|
|
|
| Secondary | Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Plasma | Relative abundance was expressed and calculated as the percentage of plasma sample radioactivity=[(radioactivity in peak)/(radioactivity in sample)]*100. Metabolites with a relative abundance ≤6% are not reported. | Enrolled participants who received study drug and had evaluable PK data. | Posted | Mean | Standard Deviation | percentage of sample radioactivity | Day 1 up to 3 days postdose. Samples collected at 2, 3, 4, 6, and 8 h postdose on Day 1 and every 24 h thereafter. |
|
|
|
| Secondary | Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Urine | Relative abundance was expressed and calculated as the percentage of administered dose excreted in urine=[(percentage of radioactivity in peak)/100]*(percentage of dose in sample). Metabolites with a relative abundance ≤1% are not reported. | Enrolled participants who received study drug and had evaluable PK data. | Posted | Mean | Standard Deviation | percentage of administered dose excreted | Predose up to 4 days postdose. Samples collected at 6-h intervals on Day 1 (0-6, 6-12, and 12-24 h postdose) and at 24-h intervals thereafter. |
|
|
|
| Secondary | Relative Abundance of LY2940680, the Metabolites of LY2940680, and LSN3185556 in Feces | Relative abundance was expressed and calculated as the percentage of the administered dose excreted in feces=[(percentage of radioactivity in peak)/100]*(percentage of dose in sample). Metabolites with a relative abundance ≤1% are not reported. | Enrolled participants who received study drug and had evaluable PK data. | Posted | Mean | Standard Deviation | percentage of administered dose excreted | Predose up to 8 days postdose. Samples collected at 24-h intervals. |
|
|
|
| 0 |
| 6 |
| 3 |
| 6 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Soft tissue mass | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Measurements |
|---|---|
|
| Whole Blood Total Radioactivity |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Metabolite M73 |
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| LSN3185556 |
|