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A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
DeLand, Florida, 32720 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02058277
Pfizer
Completed
A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers

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A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers
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
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.
Not Provided
Interventional
Phase 1
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
Drug: bosutinib or bosutinib + aprepitant
Single dose of bosutinib (500 mg) or single dose of bosutinib (500 mg) and aprepitant (125 mg)
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
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2014
June 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02058277
B1871041
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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