Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I6H-MC-MCBD | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Due to safety results from another trial of LY3023703. No participants in this study received study drug.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This type of study is called a radiolabeled study. For this study, LY3023703 (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 to healthy men. Information about any side effects that may occur will also be collected. This study will last up to 15 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [^14C]-LY3023703 | Experimental | Single oral dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [^14C]-LY3023703 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to 168 hours post dose | |
| Urinary Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to 168 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of LY3023703 and Radioactivity Maximum Observed Concentration (Cmax) | Predose up to 168 hours post dose | |
| Pharmacokinetics of LY3023703 and Radioactivity Time of Maximum Observed Concentration (Tmax) | Predose up to 168 hours post dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
18 subjects were screened and enrolled but no drug was given or other data collected due to the study being terminated.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | [^14C]-LY3023703 | Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
18 subjects were screened and enrolled but no drug was given or other data collected due to the study being terminated.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | [^14C]-LY3023703 | Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, 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, Continuous |
| 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 LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | No drug was given or data collected due to the study being terminated. | Posted | Predose up to 168 hours post dose |
|
|
Not provided
No drug was given or data collected due to the study being terminated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | [^14C]-LY3023703 | Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution. |
Not provided
Not provided
18 subjects were screened and enrolled but no drug was given or other data collected due to the study being terminated
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pharmacokinetics of LY3023703 and Radioactivity Area Under The Concentration-Time Curve From Time Zero to the Last Timepoint With a Measurable Concentration [AUC (0 to Tlast)] | Predose up to 168 hours post dose |
| Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Urine and Feces | Predose up to 168 hours post dose |
| Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Plasma | One hour post-dose up to 72 hours post dose |
| United States |
| Sex: Female, Male |
|
| Primary | Urinary Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | No drug was given or data collected due to the study being terminated. | Posted | Predose up to 168 hours post dose |
|
|
| Secondary | Pharmacokinetics of LY3023703 and Radioactivity Maximum Observed Concentration (Cmax) | No drug was given or data collected due to the study being terminated. | Posted | Predose up to 168 hours post dose |
|
|
| Secondary | Pharmacokinetics of LY3023703 and Radioactivity Time of Maximum Observed Concentration (Tmax) | No drug was given or data collected due to the study being terminated. | Posted | Predose up to 168 hours post dose |
|
|
| Secondary | Pharmacokinetics of LY3023703 and Radioactivity Area Under The Concentration-Time Curve From Time Zero to the Last Timepoint With a Measurable Concentration [AUC (0 to Tlast)] | No drug was given or data collected due to the study being terminated. | Posted | Predose up to 168 hours post dose |
|
|
| Secondary | Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Urine and Feces | No drug was given or data collected due to the study being terminated. | Posted | Predose up to 168 hours post dose |
|
|
| Secondary | Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Plasma | No drug was given or data collected due to the study being terminated. | Posted | One hour post-dose up to 72 hours post dose |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
Not provided