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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00725426
First received: July 24, 2008
Last updated: April 24, 2009
Last verified: April 2009
History of Changes
  Purpose

Study to examine whether rifampin has an effect on the pharmacokinetics of bosutinib.


Condition Intervention Phase
Healthy
 Drug: Bosutinib
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Study to Examine the Potential Effect of Rifampin on the Pharmacokinetics of Bosutinib When Administered Concomitantly to Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Pharmacokinetics (plasma concentrations) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: July 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bosutinib
 Drug: Bosutinib

  Eligibility

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

Inclusion Criteria:

  • Healthy men age 18-50
  • Healthy women of nonchildbearing potential, age 18-50
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00725426     History of Changes
Other Study ID Numbers: 3160A4-1106
Study First Received: July 24, 2008
Last Updated: April 24, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013