NCT00725426

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

April 27, 2009

Status Verified

April 1, 2009

Enrollment Period

1 month

First QC Date

July 24, 2008

Last Update Submit

April 24, 2009

Conditions

Healthy

Keywords

healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (plasma concentrations)

    4 weeks

Study Arms (1)

1

EXPERIMENTAL

Bosutinib

Drug: Bosutinib

Interventions

BosutinibDRUG
1

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Abbas R, Boni J, Sonnichsen D. Effect of rifampin on the pharmacokinetics of bosutinib, a dual Src/Abl tyrosine kinase inhibitor, when administered concomitantly to healthy subjects. Drug Metab Pers Ther. 2015 Mar;30(1):57-63. doi: 10.1515/dmdi-2014-0026.

    PMID: 25803093DERIVED

MeSH Terms

Interventions

bosutinib

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 30, 2008

Study Start

July 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

April 27, 2009

Record last verified: 2009-04