Healthy
Conditions
Keywords
Bosutinib, absolute bioavailability
Brief summary
This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period crossover study in healthy subjects.
Interventions
DRUGOral Bosutinib
a single dose of 500 mg oral bosutinib
DRUGIntravenous infusion of bosutinib
a single dose of 120 mg of bosutinib intravenous infusion (1 hour)
Sponsors
Pfizer
Study design
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the Concentration-Time Curve (AUC) | 96 hours | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 96 hours | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 96 hours | Time to Reach Maximum Observed Plasma Concentration |
| Maximum Observed Plasma Concentration (Cmax) | 96 hours | Maximum Observed Plasma Concentration |
| Systemic Clearance (CL) | 96 hours | CL is a quantitative measure of the rate at which a drug substance is removed from the body. |
| Volume of Distribution at Steady State (Vss) | 96 hours | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. |
| Plasma Decay Half-Life (t1/2) | 96 hours | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
Countries
United Kingdom
Outcome results
None listed