Status:
COMPLETED
Bosutinib In Subjects With Renal Impairment
Lead Sponsor:
Pfizer
Conditions:
Renal Disease, End-Stage
Renal Insufficiency, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 s...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01233882
Start Date
December 1 2010
End Date
June 1 2012
Last Update
July 3 2012
Active Locations (5)
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1
Pfizer Investigational Site
DeLand, Florida, United States, 32720
2
Pfizer Investigational Site
Gainesville, Florida, United States, 32608
3
Pfizer Investigational Site
Miami, Florida, United States, 33169
4
Pfizer Investigational Site
Orlando, Florida, United States, 32806