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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of the investigational drug TD-1473 compared to placebo in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-1473 for SAD | Experimental | 6 of out 8 subjects per cohort will be randomized to receive TD-1473 |
|
| Placebo for SAD | Placebo Comparator | 2 of out 8 subjects per cohort will be randomized to receive placebo |
|
| TD-1473 for MAD | Experimental | 6 of out 8 subjects per cohort will be randomized to receive TD-1473 |
|
| Placebo for MAD | Placebo Comparator | 2 of out 8 subjects per cohort will be randomized to receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-1473 for SAD | Drug | SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of SAD and MAD of TD-1473 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs | Day 1 through Day 8 (SAD) or 21 (MAD) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve (AUC) in plasma, urine and feces | Day 1 through Day 4-6 (SAD) | |
| Cmax in plasma, urine and feces | Day 1 through Day 4-6 (SAD) | |
| Tmax in plasma, urine and feces |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32161949 | Derived | Sandborn WJ, Nguyen DD, Beattie DT, Brassil P, Krey W, Woo J, Situ E, Sana R, Sandvik E, Pulido-Rios MT, Bhandari R, Leighton JA, Ganeshappa R, Boyle DL, Abhyankar B, Kleinschek MA, Graham RA, Panes J. Development of Gut-Selective Pan-Janus Kinase Inhibitor TD-1473 for Ulcerative Colitis: A Translational Medicine Programme. J Crohns Colitis. 2020 Sep 16;14(9):1202-1213. doi: 10.1093/ecco-jcc/jjaa049. |
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Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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| ID | Term |
|---|---|
| C000718529 | izencitinib |
| D064346 | Sagittal Abdominal Diameter |
| C110804 | mycophenolic adenine dinucleotide |
| ID | Term |
|---|---|
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
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| Placebo for SAD | Drug | SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose. |
|
| TD-1473 for MAD | Drug | MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing. |
|
| Placebo for MAD | Drug | MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing. |
|
| Day 1 through Day 4-6 (SAD) |
| Terminal elimination half-life (t1/2) in plasma, urine and feces | Day 1 through Day 4-6 (SAD) |
| Amount excreted in urine (Aeu) | Day 1 through Day 4-6 (SAD) |
| Amount excreted in feces (Aef) | Day 1 through Day 4-6 (SAD) |
| AUC in plasma, urine and feces | Day 1 through Day 17-19 (MAD) |
| Cmax in plasma, urine and feces | Day 1 through Day 17-19 (MAD) |
| Tmax in plasma, urine and feces | Day 1 through Day 17-19 (MAD) |
| t1/2 in plasma, urine and feces | Day 1 through Day 17-19 (MAD) |
| Aeu | Day 1 through Day 17-19 (MAD) |
| Aef | Day 1 through Day 17-19 (MAD) |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |