At a glance
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A Phase I, Fixed Sequence, Open-label, Study to Assess the Pharmacokinetics of AZD9291 in Healthy Male Volunteers When a Single Oral Dose of AZD9291 80 mg is Administered Alone and in Combination With Omeprazole
In Brief
A Phase 1 clinical trial evaluating Pharmacokinetic sampling - AZD9291, AZD9291 tablet dosing, and 2 other interventions for Healthy Volunteer. Completed, enrolled 136 participants across 2 sites.
Detailed 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
Study Details
Timeline
Interventions
Blood sampling to measure AZD9291
AZD9291 80mg tablet taken on Day 5 in Period 1 and Day 1 in Period 2.
Omeprzole taken from Days 1 to 5 in Period 1.
Blood samples to measure levels of AZ5140 and AZ7550