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PF-04634817 Renal Impairment Study

NCT01791855 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-03-01

Study results available
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Summary

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.

Conditions

  • Renal Insufficiency

Interventions

DRUG

PF-04634817

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

DRUG

PF-04634817

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

DRUG

PF-04634817

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

DRUG

PF-04634817

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-10
Primary Completion
2013-09-03
Completion
2013-09-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01791855 on ClinicalTrials.gov