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
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 April 23, 2014