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Effect of Rifampin on Bosutinib When Both Are Given to Healthy People

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ClinicalTrials.gov Identifier: NCT00725426
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : April 27, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
Study to examine whether rifampin has an effect on the pharmacokinetics of bosutinib.

Condition or disease Intervention/treatment Phase
Healthy Drug: Bosutinib Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Study to Examine the Potential Effect of Rifampin on the Pharmacokinetics of Bosutinib When Administered Concomitantly to Healthy Subjects
Study Start Date : July 2008
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Bosutinib
Drug: Bosutinib


Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics (plasma concentrations) [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men age 18-50
  • Healthy women of nonchildbearing potential, age 18-50
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725426


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00725426     History of Changes
Other Study ID Numbers: 3160A4-1106
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: April 27, 2009
Last Verified: April 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
healthy subjects

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers