A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers

NCT02058277 | Completed Phase 1

• 1 other identifier: B1871041
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

bosutinib; aprepitant; drug interaction; healthy volunteers; pharmacokinetics; chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (2)

• Area under the Concentration-Time Curve (AUC)

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

  96 hours

• Maximum Observed Plasma Concentration (Cmax)

  Cmax is the peak concentration.

  96 hours

Secondary Outcomes (5)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  96 hours

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  96 hours

• Plasma Decay Half-Life (t1/2)

  96 hours

• Apparent Oral Clearance (CL/F)

  96 hours

• Apparent Volume of Distribution (Vz/F)

  96 hours

Study Arms (1)

Healthy volunteers

OTHER

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

Drug: bosutinib or bosutinib + aprepitant

Interventions

bosutinib or bosutinib + aprepitant DRUG

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

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female subjects with an informed consent document signed and dated by the subject.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

DeLand, Florida, 32720, United States

Location

Related Publications (1)

• 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.

  PMID: 27718000 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

bosutinib; Aprepitant

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 10, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

US (1)