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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00952913
First received: August 3, 2009
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Bosutinib
Drug: Lansoprazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2 [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bosutinib
Drug: Bosutinib
4 x 100-mg oral tablets, single dose
Other Name: SKI-606
Experimental: 2
bosutinib + lansoprazole
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952913

Locations
United States, Florida
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
  More Information

Additional Information:
No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00952913     History of Changes
Other Study ID Numbers: 3160A4-1108, B1871002
Study First Received: August 3, 2009
Last Updated: April 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014