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NCT00992316 Clinical Trial

To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04531083 In Healthy Male Subjects

Pain Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00992316
Other study ID # B1351001
Secondary ID
Status Completed
Phase Phase 1
First received September 4, 2009
Last updated December 16, 2009
Start date August 2009
Est. completion date December 2009

Study information
Verified date December 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Observational

Clinical Trial Summary

The purpose of the study is to investigate the safety, toleration and pharmacokinetics of single oral doses of PF-04531083 in healthy male subjects.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 21 Years to 55 Years
Eligibility Inclusion Criteria:

- young

- healthy

- male

Exclusion Criteria:

- elderly

- unhealthy

- female

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• PF-04531083
solution. doses to be selected based upon safety/tolerability/PK at preceeding dose

Locations
Country Name City State
Belgium Pfizer Investigational Site Bruxelles

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and toleration: adverse events, supine and standing vital sign measurements,telemetry, 12-lead ECGs, blood and urine safety tests up to 48 hours Yes
Primary Plasma: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F and t½ for PF-04531083 240 hours post dose No
Primary Cmax, Tmax, AUClast, AUCinf and t½ for PF-04335882 240 hours post dose No
Primary 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. 240 hours post dose No
Secondary No secondary endpoints. No
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