Bosutinib In Subjects With Renal Impairment

NCT01233882 | Completed Phase 1

• 1 other identifier: B1871020
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 5

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.

Conditions

Renal Disease, End-Stage; Renal Insufficiency, Chronic; Renal Insufficiency, Acute

Keywords

Renal impairment; healthy volunteers

Outcome Measures

Primary Outcomes (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.

  11 days

Secondary Outcomes (1)

• Safety endpoints to include adverse events, physical examination findings, changes in clinical laboratory test results including ECGs, and changes in vital signs

  11 days

Study Arms (4)

Healthy Volunteers

EXPERIMENTAL

Drug: Bosutinib

Mild Renal Impairment

EXPERIMENTAL

Drug: Bosutinib

Moderate Renal Impairment

EXPERIMENTAL

Drug: Bosutinib

Severe Renal Impairment

EXPERIMENTAL

Drug: Bosutinib

Interventions

Bosutinib DRUG

Single dose of 200 mg of bosutinib in subjects with normal renal function

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Pfizer Investigational Site

DeLand, Florida, 32720, United States

Location

Pfizer Investigational Site

Gainesville, Florida, 32608, United States

Location

Pfizer Investigational Site

Miami, Florida, 33169, United States

Location

Pfizer Investigational Site

Orlando, Florida, 32806, United States

Location

Pfizer Investigational Site

Saint Paul, Minnesota, 55114, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Acute Kidney Injury; Renal Insufficiency

Interventions

bosutinib

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 3, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 3, 2012

Record last verified: 2012-06

Locations

US (5)