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
  Purpose

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 Intervention Phase
Renal Disease, End-Stage
Renal Insufficiency, Chronic
Renal Insufficiency, Acute
Drug: Bosutinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 34
Study Start Date: December 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01233882     History of Changes
Other Study ID Numbers: B1871020
Study First Received: October 28, 2010
Last Updated: June 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Renal impairment
healthy volunteers

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

ClinicalTrials.gov processed this record on October 20, 2014