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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-06305591 Dose 1

Group Type EXPERIMENTAL

PF-06305591

Intervention Type DRUG

single Dose

PF-06305591 Dose 2

Group Type EXPERIMENTAL

PF-06305591

Intervention Type DRUG

single Dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single Dose

Interventions

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PF-06305591

single Dose

Intervention Type DRUG

PF-06305591

single Dose

Intervention Type DRUG

Placebo

Single Dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes