PF-04634817 Renal Impairment Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-10

Study Completion Date

2013-09-03

Brief Summary

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Patients with renal impairment are the target population for PF-04634817. The clearance mechanism of this drug means that exposure may be increased in subjects with renal impairment. This study will investigate the effect of the drug in subjects with varying degrees of renal impairment. Pharmacokinetics, safety and toleration will be assessed.

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Detailed Description

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Conditions

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Renal Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min)

Mild Renal Impairment

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min)

Moderate renal impairment

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min)

Severe renal impairment

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min)

Interventions

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PF-04634817

Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min)

Intervention Type DRUG

PF-04634817

Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min)

Intervention Type DRUG

PF-04634817

Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min)

Intervention Type DRUG

PF-04634817

Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female (non child bearing potential aged 18-75 years
* Documented renal impairment (mild, moderate or severe using Cockcroft-Gault equation) or matched healthy volunteers (age, weight and gender)