Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion of Esreboxetine

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to learn more about how esreboxetine is handled by the body i.e. the absorption, metabolism and excretion of esreboxetine.

Official Title
-----------------
An Open Label, Single Oral Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Esreboxetine.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: [14C]-esreboxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects aged 45 to 65 years Body mass index (BMI=weight/height2) 18 to 30 kg/m2 Exclusion Criteria: Any clinically relevant abnormality identified on the screening medical assessment Any condition possibly affecting drug absorption Subjects with exposure to significant radiation (eg serial Xray or CT scans, barium meal etc)or who have participated in a radiolabelled study in the past 12 months, or who have occupational exposure to radioactivity History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5ounces (150ml) of wine or 12 ounces (360ml) of beer or 1.5 ounces (45ml) of hard liquor) within 6 months of screening 12-lead ECG demonstrating QTc>450mses at screening Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single oral dose of [14C]-esreboxetine<br> | Drug: [14C]-esreboxetine<br>* Single oral dose of 6mg esreboxetine in solution containing approximately 100uCi [14C]-esreboxetine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative excretion of radioactivity in urine and and faeces as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and faeces for the assessment of parent drug and metabolites of esreboxetine where possible |  | Approx 10 days | 
| Pharmacokinetic parameters of esreboxetine and identification and abundance of metabolites in plasma, urine and faeces if possible |  | Approx 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical safety data |  | Approx 10 days | 
| Pharmacokinetic parameters of plasma esreboxetine metabolites if possible |  | Approx 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiolabel ADME study Healthy volunteers