A Phase I, Open-label, Single Dose, Single-Centre Study to Assess the Absolute Bioavailability of a Single Oral Dose of AZD9291 with Respect to an Intravenous Microdose of [14C]AZD9291 in Healthy Male Subjects
18 Years - 65 Years
Endpoint Classification: Bio-availability
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Aug 2016 by AstraZeneca
No locations available
|Experimental: Bioavailability of AZD9291|
To assess the absolute bioavailability of a single oral dose of AZD9291 with respect to an intravenous microdose of [14C]AZD9291
Single oral dose of 80 mg AZD9291 tablet on Day 1 administered orally with 240 mL water following an overnight fast.
Other Name: n/a
Each healthy male subject will also receive a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.