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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00800956
First received: December 2, 2008
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Healthy
Drug: [14C]-esreboxetine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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.

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of esreboxetine and identification and abundance of metabolites in plasma, urine and faeces if possible [ Time Frame: Approx 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical safety data [ Time Frame: Approx 10 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters of plasma esreboxetine metabolites if possible [ Time Frame: Approx 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 4
Study Start Date: January 2009
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single oral dose of [14C]-esreboxetine Drug: [14C]-esreboxetine
Single oral dose of 6mg esreboxetine in solution containing approximately 100uCi [14C]-esreboxetine

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800956

Locations
United States, Washington
Pfizer Investigational Site
Tacoma, Washington, United States, 98415
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00800956     History of Changes
Other Study ID Numbers: A6061018
Study First Received: December 2, 2008
Last Updated: April 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Radiolabel ADME study Healthy volunteers

ClinicalTrials.gov processed this record on November 27, 2014