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Assessment of the Analgesic Effects of PF-06372865 in Healthy Volunteers Using Evoked Pain Endpoints

NCT ID: NCT02238717

Last Updated: 2014-12-16

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-11-30

Brief Summary

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This study will examine the activity of 2 different doses of PF-06372865 on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects.

Detailed Description

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Conditions

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Healthy

Keywords

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Pain evoked pain healthy volunteer pharmacodynamics

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-06372865 (65mg)

Group Type EXPERIMENTAL

PF-06372865 (65mg)

Intervention Type DRUG

single oral dose (65 mg)

PF-06372865 (15mg)

Group Type EXPERIMENTAL

PF-06372865 (15mg)

Intervention Type DRUG

single oral dose (15mg)

Pregabalin

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

single oral dose (300mg)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching oral placebo

Interventions

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PF-06372865 (65mg)

single oral dose (65 mg)

Intervention Type DRUG

PF-06372865 (15mg)

single oral dose (15mg)

Intervention Type DRUG

Pregabalin

single oral dose (300mg)

Intervention Type DRUG

Placebo

matching oral placebo

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

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Centre for Human Drug Research

Leiden, CL, Netherlands

Site Status

Countries

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Netherlands

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7431003&StudyName=Assessment%20of%20the%20Analgesic%20Effects%20of%20PF-06372865%20in%20Healthy%20Volunteers%20Using%20Evoked%20Pain%20Endpoints

To obtain contact information for a study center near you, click here.

Other Identifiers

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2014-003015-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7431003

Identifier Type: -

Identifier Source: org_study_id