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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-1211 dose level 1 | Experimental | Ascending doses |
|
| TD-1211 dose level 2 | Experimental | Ascending doses |
|
| TD-1211 dose level 3 | Experimental | Ascending doses |
|
| TD-1211 dose level 4 | Experimental | Ascending doses |
|
| TD-1211 OIC dose level 1 | Experimental | Ascending doses |
|
| TD-1211 OIC dose level 2 | Experimental | Ascending doses |
|
| TD-1211 OIC dose level 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-1211 | Drug | Dose level 1 |
| |
| TD-1211 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability in healthy subjects and activity in subjects with opioid-induced constipation | Daily pre and post dose assessments throughout the duration of the study period |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the multiple dose pharmacokinetics of TD-1211 following oral administration | Daily pre and post dose assessments throughout the duration of the study period |
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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 |
|---|---|---|---|---|---|---|
| Clinical Research Unit | Pasadena | California | 91105 | United States | ||
| Clinical Research Unit |
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| Experimental |
Ascending doses |
|
| TD-1211 OIC dose level 4 | Experimental | Ascending doses |
|
| TD-1211 OIC dose level 5 | Experimental | Ascending doses |
|
| Placebo | Placebo Comparator | Ascending doses |
|
| Drug |
Dose level 2 |
|
| TD-1211 | Drug | Dose level 3 |
|
| TD-1211 | Drug | Dose Level 4 |
|
| TD-1211 | Drug | Ascending doses |
|
| TD-1211 | Drug | Ascending doses |
|
| TD-1211 | Drug | Ascending doses |
|
| TD-1211 | Drug | Ascending doses |
|
| TD-1211 | Drug | Ascending doses |
|
| Placebo | Drug | Ascending doses |
|
| San Antonio |
| Texas |
| 78209 |
| United States |
| Clinical Research Unit | Salt Lake City | Utah | 84106 | United States |
| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C585268 | 3-(8-(2-(cyclohexylmethyl(2,3-dihydroxypropionyl)amino)ethyl)-8-azabicyclo(3.2.1)oct-3-yl)benzamide |
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