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| ID | Type | Description | Link |
|---|---|---|---|
| I8K-MC-JPDE | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how long it takes the body to get rid of it. In addition, the safety and tolerability of the study drug will be evaluated.
Participants will be admitted to a clinical research unit (CRU) the day before dosing. Participants remain confined to the CRU for at least 7 days. Participants may be discharged from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days post-dose (Day 22).
This study will last approximately 30 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20mg [¹⁴C]-LY3337641 | Experimental | Participants received 20 milligrams (mg) oral dose of LY3337641 containing 120 microcuries of radioactivity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [¹⁴C]-LY3337641 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urinary excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in urine samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in urine and feces. | Baseline up to 22 days |
| Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Fecal excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in fecal samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in feces. | Baseline up to 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma LY3337641 | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose | |
| Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma Radioactivity |
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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 | Madison | Wisconsin | 53704 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 20mg [¹⁴C]-LY3337641 | Participants received 20 milligrams (mg) oral dose of LY3337641 containing 120 microcuries of radioactivity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 20mg [¹⁴C]-LY3337641 | Participants received 20 mg oral dose of LY3337641 containing 120 microcuries 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 | Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urinary excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in urine samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in urine and feces. | All participants who received the study drug and have evaluable pharmacokinetic (PK) data. | Posted | Mean | Standard Deviation | Percentage of total dose | Baseline up to 22 days |
|
From Baseline to End of Study (Up to 29 Days)
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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 | 20 mg [¹⁴C]-LY3337641 | Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.0 | 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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| Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose |
| Pharmacokinetics: Maximum Observed Concentration (Cmax) of Whole Blood Radioactivity | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose |
| Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma LY3337641 | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose |
| Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma Radioactivity | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose |
| Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Whole Blood Radioactivity | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose |
| Pharmacokinetics: Total Number of Measurable Metabolites of LY3337641 in Plasma, Urine and Feces | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264, and 312 hours postdose |
| Years |
|
| 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 | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Fecal excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in fecal samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in feces. | All participants who received the study drug and have evaluable PK data. | Posted | Mean | Standard Deviation | Percentage of total dose | Baseline up to 22 days |
|
|
|
| Secondary | Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma LY3337641 | All participants who received the study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms/milliliter (ng/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose |
|
|
|
| Secondary | Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma Radioactivity | All participants who received the study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalents/g (ng-equiv/g) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose |
|
|
|
| Secondary | Pharmacokinetics: Maximum Observed Concentration (Cmax) of Whole Blood Radioactivity | All participants who received the study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma LY3337641 | All participants who received the study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hours per milliliter (ng*h/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma Radioactivity | All participants who received the study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng-equivalents*h/gram (ng-equiv*h/g) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Whole Blood Radioactivity | All participants who received the study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose |
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|
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| Secondary | Pharmacokinetics: Total Number of Measurable Metabolites of LY3337641 in Plasma, Urine and Feces | All participants who received the study drug and have evaluable PK data. | Posted | Number | Number of Metabolites | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264, and 312 hours postdose |
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|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| Change of bowel habit | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
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