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OpenTrials
Completed

NCT Number: NCT00813306

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

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.

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Key information

Conditions

Reflux Episodes Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research site

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD2066

Drug

13 mg oral solution, 1 single dose

Placebo

Drug

Oral solution, 1 single dose

Primary outcomes

  1. Manometry

    Time frame: 3.45 hours each study period

Secondary outcomes

  1. pH

    Time frame: 3.45 hours each study period

  2. Impedance

    Time frame: 3.45 hours each study period

  3. Pharmacokinetic variables

    Time frame: 3.45 hours each study period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Study completion
2009
First posted
Dec 23, 2008
Registry last updated
Dec 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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