NCT00747058

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 pain

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 4, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 8, 2010

Status Verified

January 1, 2010

Enrollment Period

4 months

First QC Date

August 18, 2008

Last Update Submit

January 7, 2010

Conditions

Pain

Keywords

phase 1, human study, healthy volunteers

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Temperature change

    continuous recording over the first 48h post dose

Study Arms (2)

healthy volunteers

EXPERIMENTAL
Drug: PF-3864086

Placebo

PLACEBO COMPARATOR
Drug: Placebo

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.

healthy volunteers
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age21 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male volunteers
  • no drug history
  • no other medication for 28 pre-dose

You may not qualify if:

  • age below 21 years
  • age above 55 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 18, 2008

First Posted

September 4, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 8, 2010

Record last verified: 2010-01

Locations

BE(1)