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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00747058

Enrollment

Registered

2008-09-04

Start date

2008-08-31

Completion date

2008-12-31

Last updated

2010-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

phase 1, human study, healthy volunteers

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).

Interventions

DRUGPF-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.

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

21 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Temperature change	continuous recording over the first 48h post dose

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026