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| ID | Type | Description | Link |
|---|---|---|---|
| I7S-MC-HBEE | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3154207. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3154207 and [14C]-LY3154207 | Experimental | A single dose of LY3154207 and [14C]-LY3154207administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3154207 | Drug | Administered orally |
| |
| [14C]-LY3154207 |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Urinary Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Baseline through 552 hours after administration of study drug |
| Fecal Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Fecal Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Baseline through 552 hours after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 | Pharmacokinetics: Cmax of LY3154207 | Predose through 144 hours after administration of study drug |
| Pharmacokinetics: 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 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 Inc | Madison | Wisconsin | 53704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33029934 | Derived | Wilbraham D, Biglan KM, Svensson KA, Tsai M, Kielbasa W. Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor-Positive Allosteric Modulator (D1PAM), in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Apr;10(4):393-403. doi: 10.1002/cpdd.874. Epub 2020 Oct 7. |
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| ID | Term |
|---|---|
| C000707472 | LY3154207 |
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| Drug |
Administered orally |
|
Pharmacokinetics: AUC(0-∞) |
| Predose through 144 hours after administration of study drug |
| Total Number of Metabolites | Total Number of Metabolites | Baseline through 552 hours after administration of study drug |