To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04531083 In Healthy Male Subjects
December 16, 2009 updated by: Pfizer
A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Parallel Group, Dose Escalation Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04531083 In Healthy Male Subjects
The purpose of the study is to investigate the safety, toleration and pharmacokinetics of single oral doses of PF-04531083 in healthy male subjects.
Study Overview
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bruxelles, Belgium, 1070
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
young, healthy male volunteers
Description
Inclusion Criteria:
- young
- healthy
- male
Exclusion Criteria:
- elderly
- unhealthy
- female
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pf-04531083
To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04531083 In Healthy Male Subjects
|
solution.
doses to be selected based upon safety/tolerability/PK at preceeding dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety and toleration: adverse events, supine and standing vital sign measurements,telemetry, 12-lead ECGs, blood and urine safety tests
Time Frame: up to 48 hours
|
up to 48 hours
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Plasma: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F and t½ for PF-04531083
Time Frame: 240 hours post dose
|
240 hours post dose
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Cmax, Tmax, AUClast, AUCinf and t½ for PF-04335882
Time Frame: 240 hours post dose
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240 hours post dose
|
|
Urine: Aet (amount excreted in urine), Aet% and CLr (for selected doses dependent on the emerging pharmacokinetic profile of PF-04531083, PF-04335882 and O-desmethyl metabolite (PF-04959926))where t = 48 hours.
Time Frame: 240 hours post dose
|
240 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
|---|
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No secondary endpoints.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
September 4, 2009
First Submitted That Met QC Criteria
October 7, 2009
First Posted (Estimate)
October 9, 2009
Study Record Updates
Last Update Posted (Estimate)
December 17, 2009
Last Update Submitted That Met QC Criteria
December 16, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B1351001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.