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

AstraZeneca1 site in 1 country40 target enrollmentDecember 2008

ConditionsReflux Episodes

InterventionsAZD2066 Placebo

DrugsAZD2066 Placebo

Overview

Phase: Phase 1
Intervention: AZD2066
Conditions: Reflux Episodes
Sponsor: AstraZeneca
Enrollment: 40
Locations: 1
Primary Endpoint: Manometry
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

November 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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.