TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A 2-Cohort Study to Evaluate the Absolute Bioavailability, Absorption, Distribution, Metabolism and Excretion of TD-1473 Following an Intravenous and an Oral Dose of [14C]-TD-1473 in Healthy Male Subjects

Conditions
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Intestinal Disorders, Bowel Diseases, Inflammatory

Intervention / Treatment
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* Drug: TD-1473 oral capsule
* Drug: [14C]-TD-1473 IV bolus
* Drug: [14C]-TD-1473 Oral Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a healthy, nonsmoking male, 19 to 55 years old, inclusive Subject has a body mass index (BMI) 19 to 32 kg/m2, inclusive, and weighs at least 50 kg Subject is healthy as determined by the PI or designee based on medical history and physical examination performed at Screening and Day -1 Additional inclusion criteria apply Exclusion Criteria: Subject has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas]) Subject has a known hypersensitivity towards medications similar to TD 1473 or excipients contained in TD 1473 Subject regularly works with ionizing radiation or radioactive material Subject has been exposed to ionizing radiations, within 1 year prior to the start of the study, as external irradiation (i.e., radiological examination including CT scan, excluding dental radiography) or internal radiation (i.e., diagnostic nuclear medicine procedure) or have participated in a radiolabeled study in the last 12 months Subject, who, for any reason, is deemed by the PI or designee or Sponsor to be inappropriate for this study or have any condition which would confound or interfere with the evaluation of the safety, tolerability, and PK of the investigational drug or prevent compliance with the study protocol Additional exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus<br>Cohort 1 - One oral dose and IV bolus administered 1 hr after oral dose of TD-1473 | Drug: TD-1473 oral capsule<br>* (Intervention description included in arm description)<br>Drug: [14C]-TD-1473 IV bolus<br>* (Intervention description included in arm description)<br>|
| Experimental: [14C]-TD-1473 Oral Capsule<br>Cohort 2 - One oral dose | Drug: [14C]-TD-1473 Oral Capsule<br>* (Intervention description included in arm description)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADME, Absolute Bioavailability, Healthy Normal Males