Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion of Esreboxetine - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00800956

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
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
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single oral dose of [14C]-esreboxetine: Experimental	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

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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6061018
Study First Received:	December 2, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00800956
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Radiolabel ADME study Healthy volunteers

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009