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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Single oral dose of [14C]-esreboxetine

Group Type EXPERIMENTAL

[14C]-esreboxetine

Intervention Type DRUG

Single oral dose of 6mg esreboxetine in solution containing approximately 100uCi \[14C\]-esreboxetine

Interventions

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[14C]-esreboxetine

Single oral dose of 6mg esreboxetine in solution containing approximately 100uCi \[14C\]-esreboxetine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes