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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C]-esreboxetine

• Registration Number: NCT00800956
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Study First Posted: 2008-12-03
• Study Start: 2009-01
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-06
• Last Update Posted: 2011-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4

Inclusion Criteria

Healthy male subjects aged 45 to 65 years Body mass index (BMI=weight/height2) 18 to 30 kg/m2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single oral dose of [14C]-esreboxetine	[14C]-esreboxetine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical safety data	Approx 10 days
Pharmacokinetic parameters of plasma esreboxetine metabolites if possible	Approx 10 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Tacoma, Washington, United States