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| ID | Type | Description | Link |
|---|---|---|---|
| I3X-MC-JHTD | Other Identifier | Eli Lilly and Company |
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This is a single dose study of radiolabelled LY2784544 in healthy male subjects to study the absorption, distribution, metabolism and excretion of LY2784544. This study is for research purposes only and is not intended to treat any medical condition.
This study is approximately 10 days long, (minimum 5 days, maximum 15 days) not including screening or follow up. Screening is required within 28 days prior to the first dose of study drug and follow up is required at least 7 days after discharge from the clinical research unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [C14]-LY2784544 | Experimental | Single 30 mg oral dose containing 100 micro curies of LY2784544 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug | Radiation | Single 30 mg oral dose containing 100 micro curies of LY2784544 |
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| Measure | Description | Time Frame |
|---|---|---|
| Urinary and fecal excretion of LY2784544 radioactivity over time expressed as a percentage of the total radioactive dose administered | Predose up to 14 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics of LY2784544 and radioactivity maximum observed concentration (Cmax) | Predose up to 14 days post dose | |
| Plasma pharmacokinetics of LY27854544 and radioactivity time of maximum observed concentration (tmax) | Predose up to 14 days post dose |
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Inclusion Criteria:
Overtly healthy males as determined by medical history and physical examination
Have a body mass index (BMI) of 19 to 29 kg/m^2, inclusive
Have clinical laboratory test results within the normal reference range for the Clinical Research Unit (CRU) or results with acceptable deviations which are judged to be not clinically significant by the investigator
Normal blood pressure (BP) and heart rate (sitting) as determined by the investigator
Have venous access sufficient to allow for blood sampling as per the study requirements
Are reliable and willing to make themselves available for the duration of the study and are willing to abide by the CRU policies and procedures and study restrictions
Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the CRU
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 | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| Plasma pharmacokinetics of LY2784544 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 14 days post dose |
| Relative abundance of LY2784544 and the metabolites of LY2784544 in urine and feces | Predose up to 14 days post dose |
| Relative abundance of LY2784544 and the metabolites of LY2784544 in plasma | Predose up to 14 days post dose |
| Plasma pharmacokinetics of LY2784544 and radioactivity half-life | Predose up to 14 days postdose |
| United States |