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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014