Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2014-08-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Bosutinib
Oral Bosutinib
a single dose of 500 mg oral bosutinib
Intravenous infusion of bosutinib
a single dose of 120 mg of bosutinib intravenous infusion (1 hour)
Interventions
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Oral Bosutinib
a single dose of 500 mg oral bosutinib
Intravenous infusion of bosutinib
a single dose of 120 mg of bosutinib intravenous infusion (1 hour)
Eligibility Criteria
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Inclusion Criteria
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, accept placement of indwelling catheter for infusion and other study procedures.
Exclusion Criteria
* A positive urine drug screen for cocaine, tetrahydrocannabinol (THC), opiates/opioids, benzodiazepines and amphetamines.
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Quotient Clinical
Ruddington Fields, Nottingham, United Kingdom
Countries
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References
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Hsyu PH, Pignataro DS, Matschke K. Absolute Bioavailability of Bosutinib in Healthy Subjects From an Open-Label, Randomized, 2-Period Crossover Study. Clin Pharmacol Drug Dev. 2018 May;7(4):373-381. doi: 10.1002/cpdd.396. Epub 2017 Oct 23.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2014-001405-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1871044
Identifier Type: -
Identifier Source: org_study_id