Spots Global Cancer Trial Database for Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers

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Trial Identification

Brief Title: Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers

Official Title: 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

Study ID: NCT02224053

Conditions

Healthy Volunteer

Interventions

Pharmacokinetic sampling - AZD9291

AZD9291 tablet dosing

Omeprazole tablet dosing

Pharmacokinetic sampling - AZ5140 and AZ7550

Study Description

Brief 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

Detailed Description: