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| ID | Type | Description | Link |
|---|---|---|---|
| I7X-EW-LLCC | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to measure how much of the specially prepared study drug, LY3202626, containing radiolabeled carbon [¹⁴C] gets into the blood stream and how long it takes the body to get rid of it.
Information about any side effects that may occur will also be collected.
Participants will stay at a clinical research unit (CRU). The study will last about 28 days (check in to follow-up) for each participant.
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]-LY3202626 | Experimental | Single oral dose of LY3202626 containing 100 micro curies of radioactivity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [¹⁴C]-LY3202626 | Drug | Administered as solution by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered. | Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met |
| Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urinary excretion of radioactivity over time was expressed as a percentage of the total radioactive dose administered | Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Radioactivity Pharmacokinetics Maximum Observed Concentration (Cmax) | Plasma radioactivity pharmacokinetics were measured by the maximum observed concentration (Cmax). | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met |
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | [¹⁴C]-LY3202626 | Single 10 milligram (mg) oral dose of LY3202626 containing 100 micro curies of radioactivity |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants
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| ID | Title | Description |
|---|---|---|
| BG000 | [¹⁴C]-LY3202626 | Single oral dose of LY3202626 containing (10 milligrams) 100 micro curies of radioactivity |
| 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 | Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered. | All participants who received the study drug and have evaluable pharmacokinetics (PK) data. | Posted | Mean | Standard Deviation | percentage of the total radioactive dose | Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met |
|
|
From Baseline through End of Study (Up to 2 Months)
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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]-LY3202626 | Single 10 mg oral dose of LY3202626 containing 100 micro curies of radioactivity |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-∞]) |
Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to infinity (AUC[0-∞]). |
| Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met |
| Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to the Last Timepoint With a Measurable Concentration (AUC[0-tlast]) | Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC[0-tlast]). | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met |
| Total Number of Metabolites Representing at Least 10% of the Total Radioactivity in Plasma | Total number of metabolites were identified in at least 10% of the total radioactivity in plasma. | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 Hours Postdose |
| Total Number of Metabolites in Excreta (Urine and Feces) That Represent at Least 10% of the Dose of Radioactivity | The total number of metabolites identified in excreta (urine and feces) that represent at least 10% of the dose of radioactivity | From Dosing Until Release Criteria Is Met |
| years |
|
| 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 |
|
| Weight | Mean | Standard Deviation | Kilogram (kg) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kilogram/Square Meter (kg/m²) |
|
| Participants |
|
|
| Primary | Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urinary excretion of radioactivity over time was expressed as a percentage of the total radioactive dose administered | All participants who received the study drug and have evaluable PK data. | Posted | Mean | Standard Deviation | percentage of the total radioactive dose | Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met |
|
|
|
| Secondary | Plasma Radioactivity Pharmacokinetics Maximum Observed Concentration (Cmax) | Plasma radioactivity pharmacokinetics were measured by the maximum observed concentration (Cmax). | All participants who received the study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/millilter (ng/mL) | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met |
|
|
|
| Secondary | Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-∞]) | Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to infinity (AUC[0-∞]). | All participants who received the study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/millilter (ng*h/mL) | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met |
|
|
|
| Secondary | Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to the Last Timepoint With a Measurable Concentration (AUC[0-tlast]) | Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC[0-tlast]). | All participants who received the study drug and have evaluable PK data. | Posted | Mean | Standard Deviation | ng*h/mL | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met |
|
|
|
| Secondary | Total Number of Metabolites Representing at Least 10% of the Total Radioactivity in Plasma | Total number of metabolites were identified in at least 10% of the total radioactivity in plasma. | All participants who received the study drug and have evaluable PK data. | Posted | Number | metabolites | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 Hours Postdose |
|
|
|
| Secondary | Total Number of Metabolites in Excreta (Urine and Feces) That Represent at Least 10% of the Dose of Radioactivity | The total number of metabolites identified in excreta (urine and feces) that represent at least 10% of the dose of radioactivity | All participants who received the study drug and had evaluable PK data. | Posted | Number | metabolites | From Dosing Until Release Criteria Is Met |
|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
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