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The purpose of the study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]TD-9855
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-9855 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-9855 | Drug | radiolabeled (100 µCi [14C]-Labeled) TD-9855 (20 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To define the routes and rates of elimination and mass balance of [14C]-labeled TD-9855 | Urinary and fecal recovery of total radioactivity. Whole blood and plasma concentrations of total radioactivity. | 1-21 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of total drug-related material and TD-9855: Cmax | Whole blood and plasma concentrations | 1-21 Days |
| PK: Tmax | Whole blood and plasma concentrations |
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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 |
|---|---|---|---|---|---|---|
| Lincoln | Nebraska | 68502 | United States |
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D009135 | Muscular Diseases |
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| ID | Term |
|---|---|
| C000601820 | ampreloxetine |
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| 1-21 Days |
| PK: AUCt | Whole blood and plasma concentrations | 1-21 Days |
| PK: AUCinf | 1-21 Days |
| PK: CL/F (Renal clearance) | Urine | 1-21 Days |
| PK: Vz/F (oral volume of distribution during the terminal phase) | 1-21 Days |
| PK: amount excreted in urine (Ae) | Urine | 1-21 Days |
| PK: CLR (Renal clearance, computed as amount recovered in urine/ AUCinf) | Urine | 8-21 Days |
| Metabolic profiles in plasma and excreta | 1-21 days |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |