CompletedNCT00992316Updated Dec 17, 2009

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

An observational study in Pain, sponsored by Pfizer. Completed at 1 site in Belgium. Open to male participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-17.

Sponsored by Pfizer · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 80
Ages: 21 Years to 55 Years
Sex: Male

Study 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.

Conditions studied

Pain

Keywords

Inflammatory pain

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 55 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

young, healthy male volunteers

Inclusion criteria

young
healthy
male

Exclusion criteria

Exclusion Criteria:

elderly
unhealthy
female

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 80 participants (actual)
Biospecimen retention: Samples with dna

Groups and cohorts

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

Interventions

DrugPF-04531083
solution. doses to be selected based upon safety/tolerability/PK at preceeding dose

What researchers measure

Primary outcomes

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
Plasma: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F and t½ for PF-04531083
Time frame: 240 hours post dose
Cmax, Tmax, AUClast, AUCinf and t½ for PF-04335882
Time frame: 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

Secondary outcomes

No secondary endpoints.

Study locations

1 site

Pfizer Investigational Site
Bruxelles, 1070, Belgium

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 17, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00992316
Lead sponsor: Pfizer
First posted: Oct 9, 2009
Start date: Aug 2009
Primary completion: Dec 2009
Completion: Dec 2009
Last update: Dec 17, 2009

Study contacts

Pfizer CT.gov Call Center

study director · Pfizer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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