Absolute Bioavailability Of Bosutinib

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Oral Bosutinib; Drug: Intravenous infusion of bosutinib

• Registration Number: NCT02192294
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Study Start: 2014-08
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-30
• Last Update Posted: 2014-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bosutinib	Intravenous infusion of bosutinib	-
Bosutinib	Oral Bosutinib	-

Primary Outcome Measures

Name	Time	Method
Area under the Concentration-Time Curve (AUC)	96 hours	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	96 hours	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time to Reach Maximum Observed Plasma Concentration (Tmax)	96 hours	Time to Reach Maximum Observed Plasma Concentration
Systemic Clearance (CL)	96 hours	CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Maximum Observed Plasma Concentration (Cmax)	96 hours	Maximum Observed Plasma Concentration
Plasma Decay Half-Life (t1/2)	96 hours	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Volume of Distribution at Steady State (Vss)	96 hours	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Ruddington Fields, Nottingham, United Kingdom