Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects

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NCT00777530

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Study Location
Utrecht, , 3584, Netherlands
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Contact
1-800-718-1021
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer, Tumors, Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. 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.

2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥ 50 kg.

3. Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Family history QT prolongation, syncope, seizure, or unexplained cardiac related
death.


2. Presence or history of any disorder that may prevent the successful completion of the
study.


3. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

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Breast Cancer, Tumors, LeukemiaStudy Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects
NCT00777530
  1. Utrecht,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects
Official Title  ICMJE Ascending Single-Dose Of The Safety, Tolerability, And Pharmacokinetics Of Bosutinib Administered Orally With Multiple Doses Of Ketoconazole To Healthy Adult Subjects.
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 profile of bosutinib when administered with multiple doses of ketoconazole and with food in healthy adult subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Breast Cancer
  • Tumors
  • Leukemia
Intervention  ICMJE Drug: Bosutinib (SKI-606)
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Bosutinib (SKI-606)
Publications * Abbas R, Leister C, El Gaaloul M, Chalon S, Sonnichsen D. Ascending single-dose study of the safety profile, tolerability, and pharmacokinetics of bosutinib coadministered with ketoconazole to healthy adult subjects. Clin Ther. 2012 Sep;34(9):2011-9.e1. doi: 10.1016/j.clinthera.2012.07.006. Epub 2012 Aug 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2008)		48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. 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.
  2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ? 50 kg.
  3. Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion criteria:

  1. Family history QT prolongation, syncope, seizure, or unexplained cardiac related death.
  2. Presence or history of any disorder that may prevent the successful completion of the study.
  3. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777530
Other Study ID Numbers  ICMJE 3160A4-1114
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP