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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777530
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : October 23, 2008
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Tumors Leukemia Drug: Bosutinib (SKI-606) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: Ascending Single-Dose Of The Safety, Tolerability, And Pharmacokinetics Of Bosutinib Administered Orally With Multiple Doses Of Ketoconazole To Healthy Adult Subjects.
Study Start Date : April 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bosutinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Bosutinib (SKI-606)


Outcome Measures
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Primary Outcome Measures :
  1. Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests. [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Blood samples [ Time Frame: 5 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777530


Locations
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Netherlands
Utrecht, Netherlands, 3584
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00777530    
Other Study ID Numbers: 3160A4-1114
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: October 23, 2008
Last Verified: October 2008