Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TD-1473 · 4 trials · 6 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 |
| 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 | 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) |
| Placebo | DRUG | - |
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 small molecule being developed for gastrointestinal conditions, including inflammatory bowel disease, ulcerative colitis, and other intestinal disorders. It has been studied in patients with active moderate to severe ulcerative colitis. The drug is still in clinical development and is not approved by the FDA.
TD-1473 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker TBPH. The company has conducted Phase 1 clinical trials of TD-1473 in the United States and other countries.
TD-1473 is in Phase 1 clinical development. Multiple Phase 1 trials have been completed, including studies in patients with ulcerative colitis and healthy volunteers. The drug remains investigational and has not received FDA approval for any indication.
TD-1473 has been studied in several completed Phase 1 trials, including NCT02818686 for active ulcerative colitis, NCT03408470 an ADME study in healthy males, NCT03555617 a food-effect and drug-drug interaction study, and NCT04587713 a bioavailability and ethnobridging PK study. These trials enrolled a total of 58 participants.
TD-1473 is a distinct investigational compound developed by Theravance Biopharma. No alternative names for TD-1473 have been reported in the clinical trial data. It is being studied specifically for gastrointestinal inflammatory conditions.