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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00800956

Run by

Pfizer

People needed

4

Starts

2009-01-01

Expected to finish

2009-02-01

Last updated by the study team

2011-04-07

Who can join

Age: 45 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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