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

Study identifier:D5160C00010

ClinicalTrials.gov identifier:NCT02224053

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Healthy Volunteer

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD9291 tablet dosing, Omeprazole tablet dosing

Sex

Male

Actual Enrollment

136

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 03 Sept 2014
Primary Completion Date: 04 Jan 2015
Study Completion Date: 04 Jan 2015

Study design

Allocation: N/A
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2017 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria