Status and phase
Conditions
Treatments
About
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
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
For inclusion in the study volunteers must fulfil the following criteria.
Volunteers must not enter the study if any of the following exclusion criteria are fulfilled:
Primary purpose
Allocation
Interventional model
Masking
136 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal