Status:
COMPLETED
Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Breast Cancer
Tumors
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and tolerability of ascending single oral doses of bosutinib administered with multiple doses of ketoconazole and to provide the pharmacokinetic profi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive on study day 1. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥ 1 year (with follicle-stimulating hormone \[FSH\] ≥ 38 mIU/mL) and must have a negative serum pregnancy test result before administration of test article.
- Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥ 50 kg.
- Healthy as determined by the investigator on the basis of screening evaluations.
- Exclusion criteria:
- Family history QT prolongation, syncope, seizure, or unexplained cardiac related death.
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00777530
Start Date
April 1 2008
End Date
August 1 2008
Last Update
October 23 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Utrecht, Netherlands, 3584