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Bosutinib In Subjects With Renal Impairment

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ClinicalTrials.gov Identifier: NCT01233882
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : July 3, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Renal Disease, End-Stage Renal Insufficiency, Chronic Renal Insufficiency, Acute Drug: Bosutinib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2010
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bosutinib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Healthy Volunteers Drug: Bosutinib
Single dose of 200 mg of bosutinib in subjects with normal renal function
Experimental: Mild Renal Impairment Drug: Bosutinib
Single dose of 200 mg of bosutinib in subjects with mild renal impairment
Experimental: Moderate Renal Impairment Drug: Bosutinib
Single dose of 200 mg of bosutinib in subjects with moderate renal impairment
Experimental: Severe Renal Impairment Drug: Bosutinib
Single dose of 200 mg of bosutinib in subjects with severe renal impairment



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233882


Locations
United States, Florida
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Pfizer Investigational Site
Gainesville, Florida, United States, 32608
Pfizer Investigational Site
Miami, Florida, United States, 33169
Pfizer Investigational Site
Orlando, Florida, United States, 32806
United States, Minnesota
Pfizer Investigational Site
Saint Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01233882     History of Changes
Other Study ID Numbers: B1871020
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: July 3, 2012
Last Verified: June 2012

Keywords provided by Pfizer:
Renal impairment
healthy volunteers

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Acute Kidney Injury
Kidney Diseases
Urologic Diseases