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

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: PF-3864086; Drug: Placebo

• Registration Number: NCT00747058
• Lead Sponsor: Pfizer

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-09-03
• Study First Posted: 2008-09-04
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-07
• Last Update Posted: 2010-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
healthy volunteers	PF-3864086	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	measured intensively in the first 48 hours and continue out to day 14
Tolerability	measured intensively in the first 48 hours and continue out to day 14

Secondary Outcome Measures

Name	Time	Method
Temperature change	continuous recording over the first 48h post dose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium