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

Completed

• Conditions: Pain
• Interventions: Drug: PF-04531083

• Registration Number: NCT00992316
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-04
• Study First Submitted QC: 2009-10-07
• Study First Posted: 2009-10-09
• Status Verified: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2009-12-16
• Last Update Posted: 2009-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• young
• healthy
• male

Exclusion Criteria

• elderly
• unhealthy
• female

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety and toleration: adverse events, supine and standing vital sign measurements,telemetry, 12-lead ECGs, blood and urine safety tests	up to 48 hours
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
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

Secondary Outcome Measures

Name	Time	Method
No secondary endpoints.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium