Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1, open-label, 2-period fixed sequence design to evaluate the interaction of
AZD9291 with omeprazole in approximately 50 healthy, adult male volunteers. Volunteers will
receive Treatment A (AZD9291 and omeprazole) in Period 1 and Treatment B (AZD9291 only) in
Period 2. The dose of AZD9291 in Period 1 and the dose of AZD9291 in Period 2 will be
separated by a washout of at least 21 days (the washout will not be more than 5 weeks). The
study will be performed at up to 2 sites in the USA and will assess the effect of omeprazole
(proton pump inhibitor) on AZD9291 exposure