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Bosutinib In Subjects With Renal Impairment

Last updated on August 9, 2018

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Study Location
Pfizer Investigational Site
DeLand, Florida, 32720 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
End-Stage Renal Disease, Chronic Renal Insufficiency, Acute Renal Insufficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 renal impairment (30 ≤ CrCl ≤50 mL/min/1.73m2), mild renal impairment (50 mL/min/1.73m2) and normal renal function (CrCl >80 mL/min/1.73m2).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT01233882
Pfizer
Completed
Bosutinib In Subjects With Renal Impairment

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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
Intervention Model: Parallel Assignment
Masking: None (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).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01233882
B1871020
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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