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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00747058

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study
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
healthy volunteers: Experimental	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: Placebo Comparator	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

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B0361006
Study First Received:	August 18, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00747058
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Pfizer:

phase 1, human study, healthy volunteers

Study placed in the following topic categories:

Pain
Healthy

ClinicalTrials.gov processed this record on January 14, 2009