Drug Interaction Study Between AZD3355 and Nexium

December 2, 2010 updated by: AstraZeneca

An Open, Randomised, Three Period Cross, Single Centre, Phase 1 Pharmacokinetic Interaction Study of the Reflux Inhibitor AZD3355 150 mg Bid and Esomeprazole 40 mg od After 7 Days of Treatment in Healthy Volunteers

The purpose of the study is to evaluate if AZD3355 and Nexium interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of written informed consent
  • Females no childbearing potential
  • Clinically normal physical findings

Exclusion Criteria:

  • Clinically significant illness within 2 weeks prior to the first dose of investigational product
  • History of clinically significant disease
  • Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
AZD3355 150 mg
Drug: AZD3355
150 mg bid, oral, 7 days
Other Names:
  • Lesogaberan
EXPERIMENTAL: 2
Esomeprazole 40mg
Drug: Esomeprazole
40 mg od, oral, 7 days
Other Names:
  • Nexium
EXPERIMENTAL: 3
AZD3355 150mg/Esomeprazole 40mg
Drug: AZD3355
150 mg bid, oral, 7 days
Other Names:
  • Lesogaberan
Drug: Esomeprazole
40 mg od, oral, 7 days
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK variables
Time Frame: Frequent sampling occasions during day 7 each treatment period
Frequent sampling occasions during day 7 each treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety variables (adverse events, blood pressure, pulse, safety lab)
Time Frame: During the whole treatment period
During the whole treatment period
4-BOH cholesterol
Time Frame: Sampling occasions during day 7 one treatment period (AZD3355 alone)
Sampling occasions during day 7 one treatment period (AZD3355 alone)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Jan Vouis, MD, Quintiles AB, Uppsala, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

May 22, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (ESTIMATE)

May 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2010

Last Update Submitted That Met QC Criteria

December 2, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9120C00016
  • EudraCt nr 2007-007128-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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