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Completed Phase 1 Interventional Accepts healthy volunteers

Bosutinib In Subjects With Renal Impairment

ClinicalTrials.gov ID: NCT01233882

Public ClinicalTrials.gov record NCT01233882. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 6:30 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label, Single-Dose, Parallel-Group Study Of The Pharmacokinetics And Safety Of Bosutinib In Subjects With Renal Impairment And Matched Healthy Adults

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01233882
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Pfizer
Industry
Enrollment
34 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2010 (Type not available)
Primary completion
Jun 2012 (Actual)
Completion
Jun 2012 (Actual)
Last update posted
Jul 3, 2012

2010 – 2012

United States locations

U.S. sites
5
U.S. states
2
U.S. cities
5
Facility City State ZIP Site status
Pfizer Investigational Site DeLand Florida 32720 —
Pfizer Investigational Site Gainesville Florida 32608 —
Pfizer Investigational Site Miami Florida 33169 —
Pfizer Investigational Site Orlando Florida 32806 —
Pfizer Investigational Site Saint Paul Minnesota 55114 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01233882, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 3, 2012 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01233882 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →