A Phase I, Open-label Study to Assess Bioavailability of a Single Oral Dose of AZD9291 vs an IV Dose of [14C]AZD9291
Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
The Sponsor is developing the study drug, AZD9291, for the potential treatment of nonsmall
cell lung cancer. Lung cancer has been the most common cancer in the world for several
decades and represents 12.8% of all new cancer cases in 2008.
The purpose of this study is to see how much AZD9291 is taken up by the body when dosed by
mouth (tablet) compared to when the study drug is dosed once by injection directly into the
vein (intravenously). The dose given directly into the vein will be radiolabelled. This means
that the test drug has a radioactive component which helps us to track where the drug is in
the body. This allows us to detect the differences between the tablet and the intravenous
dose.
The study will be performed in 12 healthy male subjects aged 18-65 years. On Day 1, subjects
will be dosed with a single oral dose of 80 milligrams AZD9291 tablet followed by 100
micrograms [14C] AZD9291 dosed as an intravenous microdose beginning 5 hours and 45 minutes
after the oral dose has been administered. Subjects will remain in the study centre until
after the 120 hour post-dose blood sample is obtained and will return to the clinic for
further visits on Day 8, 10, 15 and 22 for pharmacokinetic and safety assessments.