Conditions: Healthy Volunteer
Keywords: oncology, cancer, non small cell lung cancer, anticancer druge, omeprazole, healthy volunteer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 136
Healthy volunteers: yes

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:

Arms:
arm 1: Sequential treatments of AZD9291 + omeprazole followed by AZD9291 alone, with a washout period in between.

Interventions: intervention 1: Pharmacokinetic sampling - AZD9291 intervention 2: AZD9291 tablet dosing intervention 3: Omeprazole tablet dosing intervention 4: Pharmacokinetic sampling - AZ5140 and AZ7550
Intervention descriptions: intervention 1: Blood sampling to measure AZD9291 intervention 2: AZD9291 80mg tablet taken on Day 5 in Period 1 and Day 1 in Period 2. intervention 3: Omeprzole taken from Days 1 to 5 in Period 1. intervention 4: Blood samples to measure levels of AZ5140 and AZ7550

Protocol document: