14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations

December 6, 2010 updated by: AstraZeneca

A Double-blind, Randomized, Placebo-controlled, Single-centre Phase I Pharmacodynamic Cross-over Study to Assess the Effect of a Single Dose of AZD2066 Oral Solution in Comparison to Placebo on Transient Lower Esophageal Sphincter Relaxations (TLESRs) in Healthy Subjects

The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore the effect of a single dose of AZD2066 on the function of the cardia (the opening between the stomach and the esophagus) compared to placebo (not containing any medical substance) in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • 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

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of written consent prior to any study specific procedures.
  • Healthy subjects, age 18-45 years inclusive. Females must be of no childbearing potential or must use a highly effective contraceptive method.
  • Clinically normal physical findings and laboratory values at the time of pre-entry visit, as judged by the investigator.

Exclusion Criteria:

  • Clinically significant illness within the 2 weeks prior to the first dose of the investigational product, including a suspected/manifested infection according to WHO risk categories 2, 3 or 4, as judged by the investigator.
  • A measured LES pressure of < 5mm Hg.
  • History of previous or ongoing psychiatric disease/condition.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B
Placebo
Drug: Placebo
Oral solution, 1 single dose
Experimental: A
AZD2066
Drug: AZD2066
13 mg oral solution, 1 single dose
Drug: AZD2066
Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
Experimental: C
AZD2066
Drug: AZD2066
13 mg oral solution, 1 single dose
Drug: AZD2066
Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
Experimental: D
AZD2066
Drug: AZD2066
13 mg oral solution, 1 single dose
Drug: AZD2066
Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
Placebo Comparator: E
Placebo
Drug: Placebo
Oral solution, 1 single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Manometry
Time Frame: 3.45 hours each study period
3.45 hours each study period

Secondary Outcome Measures

Outcome Measure
Time Frame
pH
Time Frame: 3.45 hours each study period
3.45 hours each study period
Impedance
Time Frame: 3.45 hours each study period
3.45 hours each study period
Pharmacokinetic variables
Time Frame: 3.45 hours each study period
3.45 hours each study period

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Marie Sundin, AstraZeneca R&D, Mölndal, Sweden
  • Principal Investigator: Guy E Boeckxstaens, MD, PhD, Motiliteitscentrum (C2-310)Department of Gastroenterology,Academic Medical Centre

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

December 1, 2008

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 22, 2008

First Submitted That Met QC Criteria

December 22, 2008

First Posted (Estimate)

December 23, 2008

Study Record Updates

Last Update Posted (Estimate)

December 7, 2010

Last Update Submitted That Met QC Criteria

December 6, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D9126C00001

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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