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

Last updated on November 21, 2019

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Study Location
Pfizer Investigational Site
Tacoma, Washington, 98415 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Healthy male subjects aged 45 to 65 years Body mass index (BMI=weight/height2) 18 to 30
kg/m2

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00800956
Pfizer
Completed
Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion of Esreboxetine

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Descriptive Information
Brief Title  ICMJE Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion of Esreboxetine
Official Title  ICMJE An Open Label, Single Oral Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Esreboxetine.
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: [14C]-esreboxetine
Single oral dose of 6mg esreboxetine in solution containing approximately 100uCi [14C]-esreboxetine
Study Arms  ICMJE Experimental: Single oral dose of [14C]-esreboxetine
Intervention: Drug: [14C]-esreboxetine
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 2, 2008)
4
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion DateFebruary 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00800956
Other Study ID Numbers  ICMJE A6061018
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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