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This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of [14C]-TD-1473. Subjects in cohort 2 will receive a single oral dose of [14C]-TD-1473 only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-1473 oral capsule | Drug | (Intervention description included in arm description) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) in Plasma | Up to 15 days | |
| Time to maximum observed concentration (tmax) in Plasma | Up to 15 days | |
| Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma | Up to 15 days | |
| Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma | Up to 15 days | |
| Apparent terminal elimination half-life (t1/2) in Plasma | Up to 15 days | |
| Apparent clearance (Cl/F) in Plasma | Up to 15 days | |
| Apparent volume of distribution (Vz/F) in Plasma | Up to 15 days | |
| Absolute bioavailability (%F) in Plasma | Up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Amount excreted in urine (Aeu) over the sampling interval in Urine | Up to 15 days | |
| Renal clearance (CLr) in Urine | Up to 15 days | |
| The percent excreted in urine (%Feu) in Urine |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolites in Plasma | TD 1473 metabolite profiling will be performed in plasma containing sufficient amounts of radioactivity | Up to 15 days |
| Metabolites in Urine | TD 1473 metabolite profiling will be performed in urine containing sufficient amounts of radioactivity |
Inclusion Criteria:
Exclusion Criteria:
Males only
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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 |
|---|---|
| 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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| [14C]-TD-1473 IV bolus | Drug | (Intervention description included in arm description) |
|
| [14C]-TD-1473 Oral Capsule | Drug | (Intervention description included in arm description) |
|
| Up to 15 days |
| Amount excreted in feces (Aef) over the sampling interval in Feces | Up to 15 days |
| The percent excreted in feces (%Fef) | Up to 15 days |
| Up to 15 days |
| Metabolites in Feces | TD-1473 metabolite profiling will be performed in feces containing sufficient amounts of radioactivity | Up to 15 days |