Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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

Key facts

Study ID
NCT02224053
Run by
AstraZeneca
People needed
136
Starts
2014-09-01
Expected to finish
2015-01-01
Last updated by the study team
2016-06-24

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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