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This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-1473 formulation bridging & food effect | Experimental | Subjects will receive, on Day 1 of each period, a single 100 mg oral dose of the tablet formulation of TD-1473 in the fed or fasted state, or the PIC formulation of TD-1473 in the fasted state, as part of a 3-period, crossover design. |
|
| TD-1473 with Itraconazole | Experimental | Subjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1. In Period 2, subjects will receive, in the fasted state, single oral doses of 200 mg itraconazole solution on Days -4 through 7 for a total of 11 days, with a single 100 mg oral dose of the tablet formulation of TD-1473 co-administered on Day 1. |
|
| TD-1473 without Itraconazole | Experimental | Subjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-1473 | Drug | oral capsule/tablet, QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) in Plasma | Up to 8 days post-dose | |
| Time to maximum observed concentration (tmax) in Plasma | Up to 8 days post-dose | |
| Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma | Up to 8 days post-dose | |
| Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma | Up to 8 days post-dose | |
| Apparent terminal elimination half-life (t1/2) in Plasma | Up to 8 days post-dose | |
| Apparent clearance (Cl/F) in Plasma | Up to 8 days post-dose | |
| Apparent volume of distribution (Vz/F) in Plasma | Up to 8 days post-dose |
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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 |
|---|---|---|---|---|---|---|
| Celerion | 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 |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000718529 | izencitinib |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | oral solution, QD |
|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D010879 |
| Piperazines |