A Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-03864086 In Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00747058
First received: August 18, 2008
Last updated: January 7, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to determine the safety and tolerability of PF-03864086 in healthy male human volunteers. Determine the pharmacokinetics (calculations of the rate of elimination of PF-03864086 from the body once the compound is ingested).


Condition Intervention Phase
Pain
Drug: PF-3864086
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalating Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-03864086 In Healthy Male Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: measured intensively in the first 48 hours and continue out to day 14 ] [ Designated as safety issue: No ]
  • Tolerability [ Time Frame: measured intensively in the first 48 hours and continue out to day 14 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Temperature change [ Time Frame: continuous recording over the first 48h post dose ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: August 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: healthy volunteers Drug: PF-3864086
The dosage form is POS (powdered oral suspension). Each subject will have 5 periods and the frequency (and duration) is once per period. The doses have been left flexible within the protocol but are listed as: 3, 10, 30, 60, 120, 240, 480 and 720 mg with an option to insert an additional dose cohort as well.
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male volunteers
  • no drug history
  • no other medication for 28 pre-dose

Exclusion Criteria:

  • age below 21 years
  • age above 55 years
  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: NCT00747058

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: NCT00747058     History of Changes
Other Study ID Numbers: B0361006
Study First Received: August 18, 2008
Last Updated: January 7, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Pfizer:
phase 1, human study, healthy volunteers

ClinicalTrials.gov processed this record on September 16, 2014