Assessment of the Analgesic Effects of PF-05089771 and Pregabalin in Healthy Volunteers Using Evoked Pain Endpoints

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-03-31

Brief Summary

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This study will examine the activity of PF-05089771 and pregabalin, alone and in combination on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects

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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-05089771 300 mg

Group Type EXPERIMENTAL

PF-05089771 300mg

Intervention Type DRUG

PF-05089771 300 mg

PF-05089771 300 mg + pregabalin 300 mg

Group Type EXPERIMENTAL

PF-05089771 300 mg + pregabalin 300 mg

Intervention Type DRUG

PF-05089771 300 mg + pregabalin 300 mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placeco

pregabalin 300 mg

Group Type ACTIVE_COMPARATOR

pregabalin 300 mg

Intervention Type DRUG

pregabalin 300 mg

ibuprofen 600 mg

Group Type ACTIVE_COMPARATOR

ibuprofen 600 mg

Intervention Type DRUG

ibuprofen 600 mg

Interventions

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PF-05089771 300mg

PF-05089771 300 mg

Intervention Type DRUG

PF-05089771 300 mg + pregabalin 300 mg

Intervention Type DRUG

Placebo

Placeco

Intervention Type DRUG

pregabalin 300 mg

Intervention Type DRUG

ibuprofen 600 mg

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 or clinical laboratory tests. •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

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). •A positive urine drug screen

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes