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Completed

NCT Number: NCT02192294

Absolute Bioavailability Of Bosutinib

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Ruddington Fields, Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral Bosutinib

Drug

a single dose of 500 mg oral bosutinib

Intravenous infusion of bosutinib

Drug

a single dose of 120 mg of bosutinib intravenous infusion (1 hour)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 96 hours

    Maximum Observed Plasma Concentration

  2. 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)

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 96 hours

    Time to Reach Maximum Observed Plasma Concentration

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 16, 2014
Registry last updated
Oct 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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