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

NCT ID: NCT00813306

Last Updated: 2010-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Reflux Episodes

Keywords

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GERD TLESR reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

AZD2066

Group Type EXPERIMENTAL

AZD2066

Intervention Type DRUG

13 mg oral solution, 1 single dose

B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral solution, 1 single dose

C

AZD2066

Group Type EXPERIMENTAL

AZD2066

Intervention Type DRUG

Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose

D

AZD2066

Group Type EXPERIMENTAL

AZD2066

Intervention Type DRUG

Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose

E

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral solution, 1 single dose

Interventions

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AZD2066

13 mg oral solution, 1 single dose

Intervention Type DRUG

Placebo

Oral solution, 1 single dose

Intervention Type DRUG

AZD2066

Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose

Intervention Type DRUG

AZD2066

Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose

Intervention Type DRUG

Placebo

Oral solution, 1 single dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Marie Sundin

Role: STUDY_DIRECTOR

AstraZeneca R&D, Mölndal, Sweden

Guy E Boeckxstaens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Motiliteitscentrum (C2-310)Department of Gastroenterology,Academic Medical Centre

Locations

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Research site

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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D9126C00001

Identifier Type: -

Identifier Source: org_study_id