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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JADG | Other Identifier | Eli Lilly and Company |
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This is a single dose study of radiolabeled [14C]-LY3009104 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY3009104. This study requires minimum of 7 days and maximum of 22 days stay. 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 |
|---|---|---|---|
| LY3009104 | Experimental | Single 10-milligram (mg) oral dose containing 100 microcuries of 14C-labeled LY3009104 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3009104 | Drug | Administered orally |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of the Total Radioactive Dose Administered Excreted From Urine and Feces | Baseline up to 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Pharmacokinetics: LY3009104 Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] | Baseline up to 48 hours | |
| Plasma Pharmacokinetics: Radioactivity Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] |
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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, 9AM - 5PM 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, 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Madison | Wisconsin |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY3009104 (Baricitinib) | Single 10-milligram (mg) oral dose containing 100 microcuries of 14C-labeled LY3009104 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | LY3009104 | Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104 |
| 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 | Percentage of the Total Radioactive Dose Administered Excreted From Urine and Feces | Participants who took study drug. | Posted | Mean | Standard Deviation | percentage of total radioactivity | Baseline up to 120 hours |
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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 | LY3009104 | Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hyperaemia | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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| Baseline up to 48 hours |
| Plasma Pharmacokinetics: Maximum Observed LY3009104 Concentration (Cmax) | Baseline up to 48 hours |
| Plasma Pharmacokinetics: Maximum Observed Radioactivity Concentration (Cmax) | Baseline up to 48 hours |
| Plasma Pharmacokinetics: LY3009104 and Radioactivity Time to Maximum Observed Concentration (Tmax) | Baseline up to 48 hours |
| Percentage of Dose of LY3009104 and LY3009104 Metabolites in Urine | Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the urine are reported. Only those metabolites that were detectable in the urine are included in the report. | Baseline up to 48 hours |
| Percentage of Dose of LY3009104 and LY3009104 Metabolites in Feces | Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the feces are reported. Only those metabolites that were detectable in the feces are included in the report. | Baseline up to 72 hours |
| Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma | Baseline up to 24 hours |
| United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Plasma Pharmacokinetics: LY3009104 Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] | Participants who took study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanomoles/liter(h*nmol/L) | Baseline up to 48 hours |
|
|
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| Secondary | Plasma Pharmacokinetics: Radioactivity Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] | Participants who took study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanomole-equivalents/kilogram | Baseline up to 48 hours |
|
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| Secondary | Plasma Pharmacokinetics: Maximum Observed LY3009104 Concentration (Cmax) | Participants who took study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomoles/liter (nmol/L) | Baseline up to 48 hours |
|
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| Secondary | Plasma Pharmacokinetics: Maximum Observed Radioactivity Concentration (Cmax) | Participants who took study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole-equivalents/milliliter | Baseline up to 48 hours |
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| Secondary | Plasma Pharmacokinetics: LY3009104 and Radioactivity Time to Maximum Observed Concentration (Tmax) | Participants who took study drug. | Posted | Median | Full Range | hour | Baseline up to 48 hours |
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| Secondary | Percentage of Dose of LY3009104 and LY3009104 Metabolites in Urine | Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the urine are reported. Only those metabolites that were detectable in the urine are included in the report. | Participants who took study drug. | Posted | Number | percentage of dose | Baseline up to 48 hours |
|
|
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| Secondary | Percentage of Dose of LY3009104 and LY3009104 Metabolites in Feces | Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the feces are reported. Only those metabolites that were detectable in the feces are included in the report. | Participants who took study drug. | Posted | Number | percentage of dose | Baseline up to 72 hours |
|
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| Secondary | Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma | Participants who took study drug. | Posted | Number | percentage of total radioactivity | Baseline up to 24 hours |
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| 0 |
| 6 |
| 1 |
| 6 |
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| Title |
|---|
| Measurements |
|---|
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| Metabolite M22 |
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| 4 hour |
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| 8 hour |
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| 24 hour |
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