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

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00952913
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
2
Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to see if there is an effect on the pharmacokinetics of bosutinib when administered with lansoprazole.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study to Examine The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib When Administered Concomitantly To Healthy Subjects
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Bosutinib

Drug: Bosutinib
4 x 100-mg oral tablets, single dose
Other Names:
  • SKI-606

    		•
    Experimental: 2

    bosutinib + lansoprazole

    Drug: Bosutinib
    4 x 100-mg oral tablets, single dose
    Other Names:
  • SKI-606

    • Drug: Lansoprazole
    2 x 30-mg oral tablets, single daily doses for 2 days
    Other Names:
  • Prevacid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2 [1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Miami Florida United States 33126

    Sponsors and Collaborators

    • Wyeth is now a wholly owned subsidiary of Pfizer

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00952913
    Other Study ID Numbers:
    • 3160A4-1108
    • B1871002
    First Posted:
    Aug 6, 2009
    Last Update Posted:
    Apr 19, 2011
    Last Verified:
    Apr 1, 2011
    Additional relevant MeSH terms:
    Lansoprazole
    Dexlansoprazole

    Study Results

    No Results Posted as of Apr 19, 2011