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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747058
• Other study ID #: B0361006
• Status: Completed
• Phase: Phase 1
• First received: August 18, 2008
• Last updated: January 7, 2010
• Start date: August 2008
• Est. completion date: December 2008

Study information

• Verified date: January 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics		measured intensively in the first 48 hours and continue out to day 14	No
Primary	Tolerability		measured intensively in the first 48 hours and continue out to day 14	Yes
Secondary	Temperature change		continuous recording over the first 48h post dose	Yes

External Links

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