- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00952913
Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects
April 18, 2011 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Study to Examine The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib When Administered Concomitantly To Healthy Subjects
The purpose of this study is to see if there is an effect on the pharmacokinetics of bosutinib when administered with lansoprazole.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33126
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Bosutinib
|
4 x 100-mg oral tablets, single dose
Other Names:
|
EXPERIMENTAL: 2
bosutinib + lansoprazole
|
4 x 100-mg oral tablets, single dose
Other Names:
2 x 30-mg oral tablets, single daily doses for 2 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (ACTUAL)
October 1, 2009
Study Completion (ACTUAL)
October 1, 2009
Study Registration Dates
First Submitted
August 3, 2009
First Submitted That Met QC Criteria
August 4, 2009
First Posted (ESTIMATE)
August 6, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 19, 2011
Last Update Submitted That Met QC Criteria
April 18, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3160A4-1108
- B1871002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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