A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT02058277
• Recruitment Status: Completed
• First Posted: February 10, 2014
• Last Update Posted: June 24, 2014
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: February 6, 2014
• First Posted Date: February 10, 2014
• Last Update Posted Date: June 24, 2014
• Study Start Date: May 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 6, 2014)

• 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.
• Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 96 hours ]
  Cmax is the peak concentration.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 6, 2014)

• 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)
• Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 96 hours ]
  Tmax is measure how fast a drug is absorbed
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers
• Official 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

Drug: bosutinib or bosutinib + aprepitant

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

Study Arms

Healthy volunteers

Healthy volunteers taking a single dose of bosutinib and a single dose of bosutinib plus aprepitant in random order

Intervention: Drug: bosutinib or bosutinib + aprepitant

• Publications *: Hsyu PH, Pignataro DS, Matschke K. Effect of aprepitant, a moderate CYP3A4 inhibitor, on bosutinib exposure in healthy subjects. Eur J Clin Pharmacol. 2017 Jan;73(1):49-56. doi: 10.1007/s00228-016-2108-z. Epub 2016 Oct 7.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 6, 2014): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02058277
• Other Study ID Numbers: B1871041
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2014