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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00800956
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : April 7, 2011
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: [14C]-esreboxetine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label, Single Oral Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Esreboxetine.
Study Start Date : January 2009
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Experimental: Single oral dose of [14C]-esreboxetine Drug: [14C]-esreboxetine
Single oral dose of 6mg esreboxetine in solution containing approximately 100uCi [14C]-esreboxetine

Primary Outcome Measures :
  1. 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 [ Time Frame: Approx 10 days ]
  2. Pharmacokinetic parameters of esreboxetine and identification and abundance of metabolites in plasma, urine and faeces if possible [ Time Frame: Approx 10 days ]

Secondary Outcome Measures :
  1. Clinical safety data [ Time Frame: Approx 10 days ]
  2. Pharmacokinetic parameters of plasma esreboxetine metabolites if possible [ Time Frame: Approx 10 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00800956

United States, Washington
Pfizer Investigational Site
Tacoma, Washington, United States, 98415
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00800956     History of Changes
Other Study ID Numbers: A6061018
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: April 7, 2011
Last Verified: April 2011

Keywords provided by Pfizer:
Radiolabel ADME study Healthy volunteers