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

NCT02224053 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2016-06-24

Study results available
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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

Conditions

  • Healthy Volunteer

Interventions

PROCEDURE

Pharmacokinetic sampling - AZD9291

Blood sampling to measure AZD9291

DRUG

AZD9291 tablet dosing

AZD9291 80mg tablet taken on Day 5 in Period 1 and Day 1 in Period 2.

DRUG

Omeprazole tablet dosing

Omeprzole taken from Days 1 to 5 in Period 1.

PROCEDURE

Pharmacokinetic sampling - AZ5140 and AZ7550

Blood samples to measure levels of AZ5140 and AZ7550

Sponsors & Collaborators

Principal Investigators

  • Serban Ghiorghiu, MSD · AstraZeneca

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02224053 on ClinicalTrials.gov