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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
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The purpose of this study is to measure the way in which TD-1211 is absorbed and eliminated by the body and to evaluate whether it is safe and well tolerated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly | Experimental | TD-1211 Dose 1 |
|
| Younger | Experimental | TD-1211 Dose 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-1211 Dose 1 | Drug |
| ||
| TD-1211 Dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 0-96 hours | |
| AUCt | Based on samples collected 0-96 hours | |
| AUCinf | Based on samples collected 0-96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with treatment-emergent adverse events | Days 1-14 | |
| Number patients with abnormal vital sign measurements | Days 1-5 | |
| Number of patients with abnormal clinical laboratory results |
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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 |
|---|---|---|---|---|---|---|
| ICON Development Solutions | San Antonio | Texas | 78209 | United States |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D000079689 | Opioid-Induced 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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|
| Days 1-5 |
| Number of patients with abnormal corrected QTc interval | Days 1-5 |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |