An Open-label, Randomized, 2-period Crossover Study To Evaluate Absolute Bioavailability Of Bosutinib In Healthy Subjects

Pfizer1 site in 1 country14 target enrollmentAugust 2014

ConditionsHealthy

Overview

This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period crossover study in healthy subjects.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

October 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

Responsible Party

Sponsor

•Healthy male and/or female subjects (of non-childbearing potential).
•Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
•Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, accept placement of indwelling catheter for infusion and other study procedures.

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
•A positive urine drug screen for cocaine, tetrahydrocannabinol (THC), opiates/opioids, benzodiazepines and amphetamines.

Intervention: Oral Bosutinib

Intervention: Intravenous infusion of bosutinib

Area under the Concentration-Time Curve (AUC)

Time Frame: 96 hours

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(96 hours)
Time to Reach Maximum Observed Plasma Concentration (Tmax)(96 hours)
Systemic Clearance (CL)(96 hours)
Maximum Observed Plasma Concentration (Cmax)(96 hours)
Plasma Decay Half-Life (t1/2)(96 hours)
Volume of Distribution at Steady State (Vss)(96 hours)