Cold Pressor Test is Used in This Study to Assess the Effect of PF-06305591 on Pain Intensity Evoked by Cold in Healthy Male Subjects

September 16, 2013 updated by: Pfizer

A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Crossover Study To Investigate The Effects Of Pf-06305591 On Cold Pain In Healthy Male Subjects

This study will evaluate the pharmacological activity of PF-06305591 in healthy male volunteers by assessing the effects of two dose levels of PF-06305591 on cold pain intensity evoked by keeping non-dominant hand into a water bath kept at 2+/- degrees.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, B-1070
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • Subjects unable to tolerate pre-study Cpressor testing at screening.
  • Subjects with an average pain (AUC 0 to 120 sec) in the pre-study Cpressor test of less than or equal to 20.
  • Broken skin on hands or forearms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Single Dose
EXPERIMENTAL: PF-06305591 Dose 1
Drug: PF-06305591
single Dose
EXPERIMENTAL: PF-06305591 Dose 2
Drug: PF-06305591
single Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Visual Analogue Scale (VAS) Score at time X, measured within a 2 minute interval
Time Frame: 24h
Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline in a 2 minute assessment.
24h

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 24h
24h
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time Frame: 24h
24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (ESTIMATE)

March 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • B5281003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe