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Completed

NCT Number: NCT02058277

A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers

This is an open label, randomized, single dose, one cohort, two sequence, two period crossover study in healthy subjects. The primary objective of the study is to evaluate the effect of a single oral dose of aprepitant on the pharmacokinetic (PK) profile of a single oral dose of bosutinib in healthy subjects.

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Key information

Conditions

Healthy Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

DeLand, Florida, 32720, United States

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 with an informed consent document signed and dated by the subject.

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non hormonal contraception as outlined in this protocol .
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.

Treatment and study plan

bosutinib or bosutinib + aprepitant

Drug

Single dose of bosutinib (500 mg) or single dose of bosutinib (500 mg) and aprepitant (125 mg)

Primary outcomes

  1. Area under the Concentration-Time Curve (AUC)

    Time frame: 96 hours

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

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 96 hours

    Cmax is the peak concentration.

Secondary outcomes

  1. 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)

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

    Time frame: 96 hours

    Tmax is measure how fast a drug is absorbed

  3. 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.

  4. Apparent Oral Clearance (CL/F)

    Time frame: 96 hours

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  5. Apparent Volume of Distribution (Vz/F)

    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 plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of A Single Dose Of Aprepitant, A Moderate CYP3A Inhibitor On Bosutinib Administered Orally To Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 10, 2014
Registry last updated
Jun 24, 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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