Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TD-1473 [Tablet A], TD-1473 oral capsule
TD-1473 · 5 trials · 8 indications
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of TD-1473 in Plasma
Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf) of TD-1473 in Plasma
Maximum observed concentration (Cmax) of TD-1473 in Plasma
Number of participants who experience one or more treatment-emergent Adverse Events (TEAE)
Number of participants who experience one or more moderate or severe treatment-emergent Adverse Events (TEAE)
Number of participants who experience one or more serious treatment-emergent Adverse Events (TEAE)
Number of participants who experienced a Clinically Significant Clinical Laboratory Measurements
Number of participants who experienced a Clinically Significant Electrocardiogram (ECG) Result
Number of participants who experienced a Clinically Significant Vital Sign Measurement
Maximum Observed Plasma Concentration of TD-1473
Time to Reach Maximum Observed Plasma Concentration (Cmax) of TD-1473
Time to Last Quantifiable Concentration of TD-1473
Trough Concentration of TD-1473
Area Under the Concentration-time Curve from Time Zero to 4 hours Post-Dose of TD-1473
Tissue Concentration of TD-1473
| Arm | Type | Description |
|---|---|---|
| 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 | 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 |
| 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 |
| Cohort 1 | EXPERIMENTAL | Japanese subjects will receive oral doses of either TD-1473 - Dose A or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days. |
| Cohort 2 | EXPERIMENTAL | Japanese subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days. |
| Cohort 3 | EXPERIMENTAL | Caucasian subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Caucasian subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days. |
| Cohort 4 | EXPERIMENTAL | Japanese subjects will receive oral doses of either TD-1473 - Dose C or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days. |
| 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. |
| TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus | EXPERIMENTAL | Cohort 1 - One oral dose and IV bolus administered 1 hr after oral dose of TD-1473 |
| [14C]-TD-1473 Oral Capsule | EXPERIMENTAL | Cohort 2 - One oral dose |
| TD-1473 low dose | EXPERIMENTAL | 10 subjects will be randomized to receive low-dose TD-1473 orally daily for 28 days |
| TD-1473 mid dose | EXPERIMENTAL | 10 subjects will be randomized to receive mid-dose TD-1473 orally daily for 28 days |
| TD-1473 high dose | EXPERIMENTAL | 10 subjects will be randomized to receive high-dose TD-1473 orally daily for 28 days |
| Placebo | PLACEBO_COMPARATOR | 10 subjects will be randomized to receive placebo orally daily for 28 days |
| Name | Type | Description |
|---|---|---|
| TD-1473 [Tablet A] | DRUG | TD-1473 \[Tablet A\] (1 Tablet = Dose A) proposed commercial tablet formulation |
| TD-1473 [Tablet B] | DRUG | TD-1473 \[Tablet B\] (2 Tablets = Dose A) current clinical tablet formulation |
| TD-1473 - Dose A | DRUG | oral capsule/tablet, QD |
| TD-1473 - Dose B | DRUG | oral capsule/tablet, QD |
| TD-1473 - Dose C | DRUG | oral capsule/tablet, QD |
| Placebo | DRUG | oral capsule/tablet, QD |
| TD-1473 | DRUG | oral capsule/tablet, QD |
| Itraconazole | DRUG | oral solution, QD |
| TD-1473 oral capsule | DRUG | (Intervention description included in arm description) |
| [14C]-TD-1473 IV bolus | DRUG | (Intervention description included in arm description) |
| [14C]-TD-1473 Oral Capsule | DRUG | (Intervention description included in arm description) |
Inclusion Criteria: * Subject is a non-smoking male or female adult * Subject (females) must be of non-childbearing potential or if of childbearing potential, subject must not be pregnant or breastfeeding, and must agree to use highly effective birth control and must not donate ova through 30 days ...
TD-1473 is an investigational oral small molecule developed by Theravance Biopharma, Inc. (TBPH) for inflammatory bowel disease, including ulcerative colitis and active moderate disease. It is a Phase 1 asset that has been studied in healthy volunteers in the United States. TD-1473 is also known by the alternate names TD-1473 [Tablet A], TD-1473 - Dose A, TD-1473- Dose A, and TD-1473 oral capsule.
TD-1473 targets Tyk2, a kinase. Tyk2 is part of the Janus kinase family and is involved in cytokine signaling pathways relevant to inflammatory conditions. By targeting this kinase, TD-1473 is designed to act on inflammatory signaling in the gastrointestinal tract, which is the basis for its study in inflammatory bowel disease and ulcerative colitis.
TD-1473 is developed by Theravance Biopharma, Inc., which trades under the ticker TBPH. The company is the sponsor behind the clinical program for this oral small molecule in inflammatory bowel disease and related intestinal disorders.
TD-1473 is in Phase 1 development. It is an investigational drug and is not approved. The program includes completed Phase 1 studies conducted in healthy volunteers in the United States, and no active trials are currently listed for TD-1473.
TD-1473 has been evaluated in completed Phase 1 trials, including NCT04587713, a single dose bioavailability and ethnobridging PK study; NCT03750565, a multiple dose ethnobridging PK study; NCT03555617, a food-effect, drug-drug interaction, and formulation bridging study; and NCT03408470, an ADME study in healthy male subjects. All were conducted in the United States.
Yes. TD-1473 oral capsule is one of the alternate names for TD-1473, along with TD-1473 [Tablet A], TD-1473 - Dose A, and TD-1473- Dose A. These names refer to the same investigational oral small molecule developed by Theravance Biopharma for inflammatory bowel disease and ulcerative colitis.