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This is a Phase 1, 2-part, open-label study. Part A will be a formulation bridging and food effect study in healthy adult subjects. Part B will be an assessment of pharmacokinetics (PK) in healthy adult Chinese subjects.
In study Part A, healthy adult subjects will receive the following treatments in a cross-over design with a ≥10-day washout period between doses:
In study Part B, healthy adult Chinese subjects will receive Treatment A: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Sequence 1 | Experimental | Part A, Sequence 1 = Treatment (Tx) C, Tx A, Tx C, Tx A Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout between treatments |
|
| Part A, Sequence 2 | Experimental | Part A, Sequence 2: Tx D, Tx B, Tx D, Tx B Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments |
|
| Part A, Sequence 3 | Experimental | Part A, Sequence 3: Tx C, Tx A, Tx D, Tx B Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments |
|
| Part A, Sequence 4 | Experimental | Part A, Sequence 4: Tx D, Tx B, Tx C, Tx A Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments |
|
| Part A, Sequence 5 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-1473 [Tablet A] | Drug | TD-1473 [Tablet A] (1 Tablet = Dose A) proposed commercial tablet formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of TD-1473 in Plasma | Predose and at prespecified time points up to 5 days after dosing on Day 1 of each period |
| AUC0-inf | Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf) of TD-1473 in Plasma | Predose and at prespecified time points up to 5 days after dosing on Day 1 of each period |
| Cmax | Maximum observed concentration (Cmax) of TD-1473 in Plasma | Predose and at prespecified time points up to 5 days after dosing on Day 1 of each period |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number and severity of treatment emergent adverse events. | Day 1 through Day 7 of each period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theravance Biopharma Investigational Site | Cypress | California | 90630 | United States | ||
| Theravance Biopharma Investigational Site |
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
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| ID | Term |
|---|---|
| C000718529 | izencitinib |
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Part A, Sequence 5: Tx A, Tx C, Tx A, Tx C
Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments
|
| Part A, Sequence 6 | Experimental | Part A, Sequence 6: Tx B, Tx D, Tx B, Tx D Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments |
|
| Part A, Sequence 7 | Experimental | Part A, Sequence 7: Tx A, Tx C, Tx B, Tx D Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments |
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| Part A, Sequence 8 | Experimental | Part A, Sequence 8: Tx B, Tx D, Tx A, Tx C Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments |
|
| Part B,Treatment A | Experimental | Single oral dose of Treatment A on Day 1 |
|
| TD-1473 [Tablet B] | Drug | TD-1473 [Tablet B] (2 Tablets = Dose A) current clinical tablet formulation |
|
| Lincoln |
| Nebraska |
| 68502 |
| United States |