NCT00813306

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Reflux Episodes

Interventions

Type	Name	Description
DRUG	AZD2066	13 mg oral solution, 1 single dose
DRUG	Placebo	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
DRUG	AZD2066	Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
DRUG	Placebo	Oral solution, 1 single dose

Timeline

• Start date: 2008-12-01
• Completion: 2009-11-01
• First posted: 2008-12-23
• Last updated: 2010-12-07

Locations

1 site across 1 country: Netherlands