TD-1211 IV/Oral Mass Balance Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine TD-1211 is processed by the body.

Detailed Description
-----------------
This study will provide information regarding the metabolic pathway of TD 1211, the need for evaluation of potential drug-drug interactions, the need for studies in special populations and the absolute oral bioavailability of TD-1211. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of TD 1211, providing further quantitative information on the disposition of TD 1211. The results from this study will allow a more comprehensive comparison between animal and human routes of elimination and metabolic profiles of TD 1211.

Official Title
-----------------
A Single-Dose, Fixed-Sequence, Two-Period, Two-Treatment Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of TD-1211 Following an Intravenous Infusion and an Oral Dose of [14C]TD-1211 in Healthy Male Subjects

Conditions
-----------------
OIC

Intervention / Treatment
-----------------
* Drug: TD-1211 IV [C14]
* Drug: TD-1211 PO [C14]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, nonsmoking male, 18 to 50 years old, inclusive. Agrees to use a highly effective method of birth control. Body mass index (BMI) 19 to 30 kg/m2, inclusive, and weighs at least 55 kg. Willing and able to give written informed consent. Exclusion Criteria: Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. Hemoglobin <14.1 g/dL or hematocrit < 40.6% at Screening. History of hypersensitivity to drugs, or a history of or any current clinically significant hypersensitivities. 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]). Participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-1211 IV [C14]<br>TD-1211 IV [C14] | Drug: TD-1211 IV [C14]<br> <br> * Other names: TD-1211;|
| Experimental: TD-1211 PO [C14]<br>TD-1211 PO [C14] | Drug: TD-1211 PO [C14]<br> <br> * Other names: TD-1211;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) |  | 0 to 168 hours postdose | 
| Peak plasma concentration (Cmax) |  | 0 to 168 hours postdose | 
| Time to peak plasma concentration (Tmax) |  | 0 to 168 hours postdose | 
| Half-life (T 1/2) |  | 0 to 168 hours postdose | 
| Percent total recovery of radioactivity in blood, urine, and feces |  | 0 to 312 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Baseline to 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OIC, Opioid Induced Constipation, Constipation