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

An Open Label, Single Oral Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Esreboxetine.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00800956

Acronym

ADME

Enrollment

Registered

2008-12-03

Start date

2009-01-31

Completion date

2009-02-28

Last updated

2011-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Radiolabel ADME study Healthy volunteers

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.

Interventions

DRUG[14C]-esreboxetine

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

45 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Clinical safety data	Approx 10 days
Pharmacokinetic parameters of plasma esreboxetine metabolites if possible	Approx 10 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026