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Bosutinib In Subjects With Renal Impairment

NCT01233882 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-07-03

No results posted yet for this study

Summary

This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with renal impairment and matching healthy volunteers. In Stage 1, only subjects with severe renal impairment and subjects with normal renal function will be enrolled. Subjects with mild and moderate renal impairment will be enrolled in Stage 2 if the results from Stage 1 suggest a substantial difference in PK profiles between subjects with severe renal impairment and subjects with normal renal function.

Conditions

  • Renal Disease, End-Stage
  • Renal Insufficiency, Chronic
  • Renal Insufficiency, Acute

Interventions

DRUG

Bosutinib

Single dose of 200 mg of bosutinib in subjects with normal renal function

DRUG

Bosutinib

Single dose of 200 mg of bosutinib in subjects with mild renal impairment

DRUG

Bosutinib

Single dose of 200 mg of bosutinib in subjects with moderate renal impairment

DRUG

Bosutinib

Single dose of 200 mg of bosutinib in subjects with severe renal impairment

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-06-30
Completion
2012-06-30

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 NCT01233882 on ClinicalTrials.gov