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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: [14C]-esreboxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00800956

A6061018

Details and patient eligibility

About

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.

Enrollment

4 estimated patients

Sex

Male

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

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