Status:
COMPLETED
Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion of Esreboxetine
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
MALE
45-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Healthy male subjects aged 45 to 65 years Body mass index (BMI=weight/height2) 18 to 30 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00800956
Start Date
January 1 2009
End Date
February 1 2009
Last Update
April 7 2011
Active Locations (1)
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1
Pfizer Investigational Site
Tacoma, Washington, United States, 98415