Absolute Bioavailability Of Bosutinib

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Intravenous infusion of bosutinib; Drug: Oral Bosutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02192294

2014-001405-40 (EudraCT Number)

B1871044

Details and patient eligibility

About

This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period crossover study in healthy subjects.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

14 participants in 1 patient group

Bosutinib

Experimental group

Treatment:

Drug: Intravenous infusion of bosutinib

Drug: Oral Bosutinib