38
Participants
Start Date
November 14, 2014
Primary Completion Date
March 24, 2015
Study Completion Date
January 24, 2023
AZD9291 tablets
AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months.
Pharmacokinetic sampling - AZD9291
Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.
Dietary Fasted
Fasted from 10 hours prior to dosing with 80mg AZD9291 tablet and 4 hours after dosing
Dietary High Fat
Allocated breakfast prior to dosing with 80mg AZD9291 tablet
Pharmacokinetic sampling - AZ5140 and AZ7550
Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.
Research Site, Dijon
Research Site, Madrid
Research Site, Madrid
Research Site, Madrid
Research Site, Seville
Research Site, Saint-Herblain
Research Site, Lyon
Research Site, Seoul
Research Site, Seoul
Research Site, London
Research Site, Manchester
Research Site, Newcastle upon Tyne
Research Site, Sutton
Lead Sponsor
AstraZeneca
INDUSTRY