Absolute Bioavailability Of Bosutinib
An Open-label, Randomized, 2-period Crossover Study To Evaluate Absolute Bioavailability Of Bosutinib In Healthy Subjects
2 other identifiers
interventional
14
1 country
1
Brief Summary
This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period crossover study in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Aug 2014
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 31, 2014
October 1, 2014
2 months
July 14, 2014
October 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area under the Concentration-Time Curve (AUC)
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
96 hours
Secondary Outcomes (6)
Maximum Observed Plasma Concentration (Cmax)
96 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
96 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
96 hours
Plasma Decay Half-Life (t1/2)
96 hours
Systemic Clearance (CL)
96 hours
- +1 more secondary outcomes
Study Arms (1)
Bosutinib
EXPERIMENTALInterventions
a single dose of 120 mg of bosutinib intravenous infusion (1 hour)
Eligibility Criteria
You may qualify if:
- Healthy male and/or female subjects (of non-childbearing potential).
- 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.
You may not qualify if:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
- A positive urine drug screen for cocaine, tetrahydrocannabinol (THC), opiates/opioids, benzodiazepines and amphetamines.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Quotient Clinical
Ruddington Fields, Nottingham, NG11 6JS, United Kingdom
Related Publications (1)
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.
PMID: 29058816DERIVED
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2014
First Posted
July 16, 2014
Study Start
August 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
October 31, 2014
Record last verified: 2014-10