Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TD-1211 · 6 trials · 5 indications
Assess the effect of CYP3A4 and P gp inhibition with itraconazole on the PK disposition of a single oral dose of TD-1211 Endpoints included plasma PK parameters for TD-1211: * AUC * Cmax * Tmax * t1/2 * CL/F * Vz/F
| Arm | Type | Description |
|---|---|---|
| Dose 1 | EXPERIMENTAL | - |
| Dose 2 | EXPERIMENTAL | - |
| Dose 3 | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | - |
| 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 |
| Active | EXPERIMENTAL | Escalating Doses of TD-1211 |
| TD-1211 IV [C14] | EXPERIMENTAL | TD-1211 IV \[C14\] |
| TD-1211 PO [C14] | EXPERIMENTAL | TD-1211 PO \[C14\] |
| TD-1211 | ACTIVE_COMPARATOR | - |
| TD-1211+ itraconazole | ACTIVE_COMPARATOR | - |
| 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 IV [C14] | DRUG | - |
| TD-1211 PO [C14] | DRUG | - |
| TD-1211+ itraconazole | DRUG | Period 2 |
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 opioid-induced constipation (OIC). It has been studied in patients with OIC and in healthy volunteers. The drug is not approved and remains in clinical development.
TD-1211 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company. The company's stock trades under the ticker symbol TBPH.
TD-1211 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not received FDA approval. All trials listed for TD-1211 are completed, with no active trials currently ongoing.
TD-1211 has been studied in several completed trials, including NCT01040637, a Phase 1 multiple-dose study in healthy volunteers and OIC patients; NCT01333540 and NCT01401985, both Phase 2 studies in OIC patients; and NCT01568411, a Phase 1 drug-drug interaction study in healthy volunteers.
TD-1211 is the primary name used in clinical trials. No alternative names have been reported for this investigational drug. It is a small molecule being evaluated specifically for opioid-induced constipation.