Safety And Tolerability Study Of BID Titration Scheme With PF-05089771

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-04-30

Brief Summary

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The most notable tolerability finding from these multiple dosing studies has been the occurrence of mild to moderate rash at doses of 450 mg BID and 600 mg BID. Based upon this finding, the current four week study is designed to examine whether a slow titration regimen up to a lower maintenance dose of 450 mg BID is able to reduce the incidence of rash.

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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

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A - active treatment

Group Type EXPERIMENTAL

PF-05089771

Intervention Type DRUG

titration from 150mg BID to 450mg BID

Arm B - placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matched placebo

Interventions

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PF-05089771

titration from 150mg BID to 450mg BID

Intervention Type DRUG

Placebo

matched placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects of non-child bearing potential 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

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal (ie, recurrent nephrolitisis), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* History of, or presence of allergic skin reactions or active skin disease (except for subjects with acne who may be included in the study) at the time of screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes