Effect of Rifampin on Bosutinib When Both Are Given to Healthy People
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00725426
Collaborator
(none)
24
1
1
Study Details
Study Description
Brief Summary
Study to examine whether rifampin has an effect on the pharmacokinetics of bosutinib.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Anticipated 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
:
Jul 1, 2008
Actual Primary Completion Date
:
Aug 1, 2008
Actual Study Completion Date
:
Aug 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Bosutinib |
Drug: Bosutinib
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics (plasma concentrations) [4 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy men age 18-50
-
Healthy women of nonchildbearing potential, age 18-50
Contacts and Locations
Locations
No locations specified.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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00725426
Other Study ID Numbers:
- 3160A4-1106
First Posted:
Jul 30, 2008
Last Update Posted:
Apr 27, 2009
Last Verified:
Apr 1, 2009
Keywords provided by ,
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