Bosutinib In Subjects With Renal Impairment

NCT01233882

Last updated date
Study Location
Pfizer Investigational Site
DeLand, Florida, 32720, United States
Contact
1-800-718-1021

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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 <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
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).

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End-Stage Renal Disease, Chronic Renal Insufficiency, Acute Renal InsufficiencyBosutinib In Subjects With Renal Impairment NCT01233882
  1. DeLand, Florida
  2. Gainesville, Florida
  3. Miami, Florida
  4. Orlando, Florida
  5. Saint Paul, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Bosutinib In Subjects With Renal Impairment
Official Title  ICMJE An Open-Label, Single-Dose, Parallel-Group Study Of The Pharmacokinetics And Safety Of Bosutinib In Subjects With Renal Impairment And Matched Healthy Adults
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Renal Disease, End-Stage
  • Renal Insufficiency, Chronic
  • Renal Insufficiency, Acute
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2012)
34
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2010)
32
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01233882
Other Study ID Numbers  ICMJE B1871020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2012

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