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

Pfizer28 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain

Interventions

PF-3864086DRUG

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.

PlaceboDRUG

Placebo

Eligibility

Sex: MALEMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

Pharmacokinetics

Time frame: measured intensively in the first 48 hours and continue out to day 14

Tolerability

Time frame: measured intensively in the first 48 hours and continue out to day 14

Secondary Outcomes

Temperature change

Time frame: continuous recording over the first 48h post dose

Data from ClinicalTrials.gov

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