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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
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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 June 17, 2013