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| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-MC-JPBD | Other Identifier | Eli Lilly and Company |
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This type of study is called a radiolabeled study. For this study, LY2835219 (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 help understand how the drug appears in the blood, urine, and stool after it is administered.
In addition, this study will also evaluate the safety and tolerability of a single dose of LY2835219 when given to healthy participants. Information about any side effects that may occur will also be collected.
This study will last about 3 weeks for each participant, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [^14C]-LY2835219 | Experimental | Single 150 milligram (mg) oral dose solution of LY2835219 containing 5 micro-curies of (µCi) [^14C] labeled drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [^14C]-LY2835219 | Drug | Administered as oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary and Fecal Excretion of LY2835219-Related 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 or feces = (amount of radioactive dose recovered in urine or feces / total radioactive dose administered) * 100. | Predose up to Day 14 postdose; Fecal samples collected at 24-hour (h) intervals; Urine collected at 0 to 6 h, 6 to 12 h, and 12 to 24 h postdose and at 24-h intervals thereafter up to Day 14 postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Pharmacokinetics (PK) of LY2835219 and Metabolite of LY2835219: Maximum Observed Concentration (Cmax) | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose | |
| Plasma PK of Radioactivity: Cmax |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | [^14C]-LY2835219 | Single 150-milligram (mg) LY2835219 dose containing 5 micro- curies (µCi) of carbon-14-labeled LY2835219 ([^14C]-LY2835219), administered as an oral solution. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | [^14C]-LY2835219 | Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, 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, Categorical | 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 | Urinary and Fecal Excretion of LY2835219-Related 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 or feces = (amount of radioactive dose recovered in urine or feces / total radioactive dose administered) * 100. | Participants who received study drug. | Posted | Mean | Standard Deviation | percentage radioactive dose administered | Predose up to Day 14 postdose; Fecal samples collected at 24-hour (h) intervals; Urine collected at 0 to 6 h, 6 to 12 h, and 12 to 24 h postdose and at 24-h intervals thereafter up to Day 14 postdose |
|
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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]-LY2835219 | Single 150-mg LY2835219 dose containing 5 µCi of [^14C]-LY2835219, administered as an oral solution. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vessel Puncture Site Haematoma | General disorders | 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 |
|---|---|
| C000590451 | abemaciclib |
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| Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
| Plasma PK of LY2835219, Metabolite of LY2835219, and Radioactivity: Time of Maximum Observed Concentration (Tmax) | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
| Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration-Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
| Plasma PK of Radioactivity: AUC(0 to Tlast) | The PK of radioactivity was measured as nanogram equivalents times hours per gram (ng Eq*h/g). | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
| Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
| Plasma PK of Radioactivity: AUC(0-∞) | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
| Relative Abundance of LY2835219 and Metabolites of LY2835219 Eliminated in Urine and Feces | The abundance (as percentage dose) of LY2835219 or its metabolites eliminated in feces is calculated as = (amount of LY2835219 or its metabolites recovered in feces / total amount administered) * 100. Due to low radioactivity of dose recovered in urine, further quantitative profiling of urine was not conducted. | Predose through 216 h postdose; Fecal samples collected at 24-h intervals |
| Relative Abundance of LY2835219 and Metabolites of LY2835219 in Plasma | The relative abundance of LY2835219 or its metabolites in plasma were estimated based on AUC(0-∞) and reported as a percentage of total plasma radioactivity. The relative abundance of LY2835219 or its metabolites calculated as = [AUC (0-∞) of LY2835219 or its metabolites in plasma / AUC (0-∞) of total plasma radioactivity] * 100. | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
| United States |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Plasma Pharmacokinetics (PK) of LY2835219 and Metabolite of LY2835219: Maximum Observed Concentration (Cmax) | Participants who received study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
|
|
|
| Secondary | Plasma PK of Radioactivity: Cmax | Participants who received study drug and had evaluable PK Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalents per gram (ng Eq/g) | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
|
|
|
| Secondary | Plasma PK of LY2835219, Metabolite of LY2835219, and Radioactivity: Time of Maximum Observed Concentration (Tmax) | Participants who received study drug and evaluable PK tmax data. | Posted | Median | Full Range | h | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
|
|
|
| Secondary | Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration-Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | Participants who received study drug and had evaluable PK AUC(0-tlast) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
|
|
|
| Secondary | Plasma PK of Radioactivity: AUC(0 to Tlast) | The PK of radioactivity was measured as nanogram equivalents times hours per gram (ng Eq*h/g). | Participants who received study drug and had evaluable PK AUC(0-tlast) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng Eq*h/g | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
|
|
|
| Secondary | Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] | Participants who received study drug and had evaluable PK AUC(0-∞) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
|
|
|
| Secondary | Plasma PK of Radioactivity: AUC(0-∞) | Participants who received study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng Eq*h/g | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
|
|
|
| Secondary | Relative Abundance of LY2835219 and Metabolites of LY2835219 Eliminated in Urine and Feces | The abundance (as percentage dose) of LY2835219 or its metabolites eliminated in feces is calculated as = (amount of LY2835219 or its metabolites recovered in feces / total amount administered) * 100. Due to low radioactivity of dose recovered in urine, further quantitative profiling of urine was not conducted. | Participants who received study drug and had evaluable PK data. No participants were analyzed for relative abundance of LY2835219 and metabolites of LY2835219 in urine. | Posted | Number | percentage of radioactive dose excreted | Predose through 216 h postdose; Fecal samples collected at 24-h intervals |
|
|
|
| Secondary | Relative Abundance of LY2835219 and Metabolites of LY2835219 in Plasma | The relative abundance of LY2835219 or its metabolites in plasma were estimated based on AUC(0-∞) and reported as a percentage of total plasma radioactivity. The relative abundance of LY2835219 or its metabolites calculated as = [AUC (0-∞) of LY2835219 or its metabolites in plasma / AUC (0-∞) of total plasma radioactivity] * 100. | Participants who received study drug and had evaluable PK AUC(0-∞) data. | Posted | Number | percentage of total plasma radioactivity | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose |
|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| Vessel Puncture Site Pain | General disorders | Systematic Assessment |
|
| Vessel Puncture Site Swelling | General disorders | Systematic Assessment |
|
| Folliculitis | Infections and infestations | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Measurements |
|---|
|