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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00992316

Enrollment

Registered

2009-10-09

Start date

2009-08-31

Completion date

2009-12-31

Last updated

2009-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Inflammatory pain

Brief 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.

Interventions

DRUGPF-04531083

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* young * healthy * male

Exclusion criteria

* elderly * unhealthy * female

Design outcomes

Primary

Measure	Time frame
Safety and toleration: adverse events, supine and standing vital sign measurements,telemetry, 12-lead ECGs, blood and urine safety tests	up to 48 hours
Plasma: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F and t½ for PF-04531083	240 hours post dose
Cmax, Tmax, AUClast, AUCinf and t½ for PF-04335882	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.	240 hours post dose

Secondary

Measure	Time frame
No secondary endpoints.	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026