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The purpose of this study is to determine TD-1211 is processed by the body.
This study will provide information regarding the metabolic pathway of TD 1211, the need for evaluation of potential drug-drug interactions, the need for studies in special populations and the absolute oral bioavailability of TD-1211. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of TD 1211, providing further quantitative information on the disposition of TD 1211. The results from this study will allow a more comprehensive comparison between animal and human routes of elimination and metabolic profiles of TD 1211.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-1211 IV [C14] | Experimental | TD-1211 IV [C14] |
|
| TD-1211 PO [C14] | Experimental | TD-1211 PO [C14] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-1211 IV [C14] | Drug |
|
| |
| TD-1211 PO [C14] |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | 0 to 168 hours postdose | |
| Peak plasma concentration (Cmax) | 0 to 168 hours postdose | |
| Time to peak plasma concentration (Tmax) | 0 to 168 hours postdose | |
| Half-life (T 1/2) | 0 to 168 hours postdose | |
| Percent total recovery of radioactivity in blood, urine, and feces | 0 to 312 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Baseline to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
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| ID | Term |
|---|---|
| C000615234 | Carbon-14 |
| C585268 | 3-(8-(2-(cyclohexylmethyl(2,3-dihydroxypropionyl)amino)ethyl)-8-azabicyclo(3.2.1)oct-3-yl)benzamide |
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| Drug |
|
|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |