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Bosutinib In Subjects With Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01233882
First received: October 28, 2010
Last updated: June 29, 2012
Last verified: June 2012

October 28, 2010
June 29, 2012
December 2010
June 2012   (final data collection date for primary outcome measure)
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. [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01233882 on ClinicalTrials.gov Archive Site
Safety endpoints to include adverse events, physical examination findings, changes in clinical laboratory test results including ECGs, and changes in vital signs [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
Safety endpoints to include adverse events, physical examination findings, changes in clinical laboratory test results including ECGs, and changes in vital signs [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Disease, End-Stage
  • Renal Insufficiency, Chronic
  • Renal Insufficiency, Acute
  • 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
  • Experimental: Healthy Volunteers
    Intervention: Drug: Bosutinib
  • Experimental: Mild Renal Impairment
    Intervention: Drug: Bosutinib
  • Experimental: Moderate Renal Impairment
    Intervention: Drug: Bosutinib
  • Experimental: Severe Renal Impairment
    Intervention: Drug: Bosutinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
June 2012
June 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01233882
B1871020
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP