Bosutinib In Subjects With Renal Impairment

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01233882

Enrollment

Registered

2010-11-03

Start date

2010-12-31

Completion date

2012-06-30

Last updated

2012-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Renal impairment, healthy volunteers

Brief 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.

Interventions

DRUGBosutinib

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Males and females, aged 18 to 65. * Adequate hepatic function. * Documented creatinine clearance by Cockroft-Gault formula indicative of the respective level of renal impairment: Severe renal impairment (CrCl \<30 mL/min/1.73m2), moderate renal impairment (30 ≤ CrCl ≤50 mL/min/1.73m2), mild renal impairment (50 \< CrCl≤80 mL/min/1.73m2) and normal renal function (CrCl \>80 mL/min/1.73m2).

Exclusion criteria

* Use of any investigational drug or biologic within 4 weeks prior to the screening visit of during the screening period. * Ongoing treatment with Digoxin or strong CYP3A4 inhibitors or inducers. * Uncontrolled hypertension (for renally impaired subjects only).

Design outcomes

Primary

Measure	Time frame
Serum concentrations of bosutinib and its active metabolites will be measured, PK parameters (AUCinf, Cmax, AUClast, Tmax, t1/2, Cl/F and Vz/F) of bosutinib and its active metabolites will be calculated.	11 days

Secondary

Measure	Time frame
Safety endpoints to include adverse events, physical examination findings, changes in clinical laboratory test results including ECGs, and changes in vital signs	11 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026