NCT00992316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 17, 2009

Status Verified

December 1, 2009

Enrollment Period

4 months

First QC Date

September 4, 2009

Last Update Submit

December 16, 2009

Conditions

Pain

Keywords

Inflammatory pain

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • No secondary endpoints.

Study Arms (1)

Pf-04531083

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

Drug: PF-04531083

Interventions

PF-04531083DRUG

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

Pf-04531083

Eligibility Criteria

Age21 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

young, healthy male volunteers

You may qualify if:

  • young
  • healthy
  • male

You may not qualify if:

  • elderly
  • unhealthy
  • female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 4, 2009

First Posted

October 9, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 17, 2009

Record last verified: 2009-12

Locations

BE(1)