Absolute Bioavailability Of Bosutinib

October 30, 2014 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottingham
      • Ruddington Fields, Nottingham, United Kingdom, NG11 6JS
        • Quotient Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bosutinib
Drug: Oral Bosutinib
a single dose of 500 mg oral bosutinib
Drug: Intravenous infusion of bosutinib
a single dose of 120 mg of bosutinib intravenous infusion (1 hour)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
96 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: 96 hours
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
96 hours
Plasma Decay Half-Life (t1/2)
Time Frame: 96 hours
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
96 hours
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 96 hours
Maximum Observed Plasma Concentration
96 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 96 hours
Time to Reach Maximum Observed Plasma Concentration
96 hours
Systemic Clearance (CL)
Time Frame: 96 hours
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
96 hours
Volume of Distribution at Steady State (Vss)
Time Frame: 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.
96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 30, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B1871044
  • 2014-001405-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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