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

Last updated on August 9, 2018

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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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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.
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
Drug: [14C]-esreboxetine
Single oral dose of 6mg esreboxetine in solution containing approximately 100uCi [14C]-esreboxetine
Experimental: Single oral dose of [14C]-esreboxetine
Intervention: Drug: [14C]-esreboxetine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
February 2009
February 2009   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: Male
45 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00800956
A6061018
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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