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Also known as TD-1211 IV [C14], TD-1211 Dose 1, TD-1211 PO [C14]
TD-1211 · 6 trials · 6 indications
| Arm | Type | Description |
|---|---|---|
| Dose 1 | EXPERIMENTAL | - |
| Dose 2 | EXPERIMENTAL | - |
| Dose 3 | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | - |
| Active | EXPERIMENTAL | Escalating Doses of TD-1211 |
| Cohort 1 | EXPERIMENTAL | 5 mg TD-1211 once daily for 4 days followed by 10 mg for 14 days |
| Cohort 2 | EXPERIMENTAL | 5 mg TD-1211 once daily for 4 days followed by 15 mg for 14 days |
| Cohort 3 | EXPERIMENTAL | 5 mg TD-1211 once daily for 2 days followed by 10 mg for 14 days |
| Cohort 4 | EXPERIMENTAL | 5 mg TD-1211 once daily for 2 days followed by 15 mg for 14 days |
| Cohort 5 | EXPERIMENTAL | 2 mg TD-1211 once daily for 14 days |
| Cohort 6 | EXPERIMENTAL | 2.5 mg TD-1211 every 6 hours for 14 days |
| Elderly | EXPERIMENTAL | TD-1211 Dose 1 |
| Younger | EXPERIMENTAL | TD-1211 Dose 2 |
| TD-1211 IV [C14] | EXPERIMENTAL | TD-1211 IV \[C14\] |
| TD-1211 PO [C14] | EXPERIMENTAL | TD-1211 PO \[C14\] |
| 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 | EXPERIMENTAL | Ascending doses |
| TD-1211 OIC dose level 4 | EXPERIMENTAL | Ascending doses |
| TD-1211 OIC dose level 5 | EXPERIMENTAL | Ascending doses |
| Name | Type | Description |
|---|---|---|
| TD-1211 | DRUG | once daily |
| Placebo | DRUG | Once daily |
| TD-1211 Dose 1 | DRUG | - |
| TD-1211 Dose 2 | DRUG | - |
| TD-1211 IV [C14] | DRUG | - |
| TD-1211 PO [C14] | DRUG | - |
Inclusion Criteria: * History of constipation with onset after initiation of opioid therapy * Self-reported OIC of approximately 3 spontaneous bowel movements (SBMs) per week or less for each week over at least the previous two week period * Have used chronic opioids with a total daily dose ≥30 mg ...
TD-1211 is an investigational small molecule being developed for gastrointestinal conditions, specifically constipation and opioid-induced constipation (OIC). It has been studied in Phase 1 and Phase 2 clinical trials in patients with OIC and in healthy subjects with constipation. It is not approved for any indication.
TD-1211 is being developed by Theravance Biopharma, Inc., which trades on the Nasdaq under the ticker TBPH. The company has sponsored the clinical trials evaluating the drug in constipation and opioid-induced constipation.
TD-1211 is in Phase 1 development. Four clinical trials have been completed, including two Phase 1 studies and two Phase 2 studies, with a total enrollment of 483 participants. No trials are currently active.
TD-1211 has been evaluated in four completed trials: NCT01702194, a Phase 1 mass balance study; NCT01655771, a Phase 1 single-dose study in elderly and young healthy subjects; NCT01459926, a Phase 2 study in opioid-induced constipation; and NCT01401985, a Phase 2 study in OIC.
Yes, TD-1211 IV [C14] and TD-1211 Dose 1 are alternative names for TD-1211. These designations refer to specific formulations or dose levels used in clinical studies of the same investigational compound.