Bosutinib In Subjects With Renal Impairment

Renal Insufficiency, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233882
• Other study ID #: B1871020
• Status: Completed
• Phase: Phase 1
• First received: October 28, 2010
• Last updated: June 29, 2012
• Start date: December 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Failure, Chronic
• Renal Disease, End-Stage
• Renal Insufficiency
• Renal Insufficiency, Acute
• Renal Insufficiency, Chronic

Intervention

Drug:
• Bosutinib
Single dose of 200 mg of bosutinib in subjects with normal renal function
• Bosutinib
Single dose of 200 mg of bosutinib in subjects with mild renal impairment
• Bosutinib
Single dose of 200 mg of bosutinib in subjects with moderate renal impairment
• Bosutinib
Single dose of 200 mg of bosutinib in subjects with severe renal impairment

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	DeLand	Florida
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		11 days	Yes
Secondary	Safety endpoints to include adverse events, physical examination findings, changes in clinical laboratory test results including ECGs, and changes in vital signs		11 days	Yes

External Links

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