Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects

NCT00952913

Last updated date
Study Location
Pfizer Investigational Site
Miami, Florida, 33126, United States
Contact
1-800-718-1021

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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
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy men and women of nonchildbearing potential, between the ages of 18 to 50 years old.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Any cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine,
immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects
Official Title  ICMJE A Study to Examine The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib When Administered Concomitantly To Healthy Subjects
Brief Summary The purpose of this study is to see if there is an effect on the pharmacokinetics of bosutinib when administered with lansoprazole.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Bosutinib
    4 x 100-mg oral tablets, single dose
    Other Name: SKI-606
  • Drug: Lansoprazole
    2 x 30-mg oral tablets, single daily doses for 2 days
    Other Name: Prevacid
Study Arms  ICMJE
  • Experimental: 1
    Bosutinib
    Intervention: Drug: Bosutinib
  • Experimental: 2
    bosutinib + lansoprazole
    Interventions:
    • Drug: Bosutinib
    • Drug: Lansoprazole
Publications * Abbas R, Leister C, Sonnichsen D. A clinical study to examine the potential effect of lansoprazole on the pharmacokinetics of bosutinib when administered concomitantly to healthy subjects. Clin Drug Investig. 2013 Aug;33(8):589-95. doi: 10.1007/s40261-013-0103-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2009)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy men and women of nonchildbearing potential, between the ages of 18 to 50 years old.

Exclusion Criteria:

  • Any cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00952913
Other Study ID Numbers  ICMJE 3160A4-1108
B1871002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP