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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00992316
First received: September 4, 2009
Last updated: December 16, 2009
Last verified: December 2009
  Purpose

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


Condition Intervention Phase
Pain
Drug: PF-04531083
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Plasma: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F and t½ for PF-04531083 [ Time Frame: 240 hours post dose ] [ Designated as safety issue: No ]
  • Cmax, Tmax, AUClast, AUCinf and t½ for PF-04335882 [ Time Frame: 240 hours post dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No secondary endpoints. [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 80
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pf-04531083
To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04531083 In Healthy Male Subjects
Drug: PF-04531083
solution. doses to be selected based upon safety/tolerability/PK at preceeding dose

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

young, healthy male volunteers

Criteria

Inclusion Criteria:

  • young
  • healthy
  • male

Exclusion Criteria:

  • elderly
  • unhealthy
  • female
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992316

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00992316     History of Changes
Other Study ID Numbers: B1351001
Study First Received: September 4, 2009
Last Updated: December 16, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Pfizer:
Inflammatory pain

ClinicalTrials.gov processed this record on November 20, 2014