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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00813306

Enrollment

Registered

2008-12-23

Start date

2008-12-31

Completion date

2009-11-30

Last updated

2010-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reflux Episodes

Keywords

GERD, TLESR, reflux

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.

Interventions

DRUGAZD2066

13 mg oral solution, 1 single dose

DRUGPlacebo

Oral solution, 1 single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Manometry	3.45 hours each study period

Secondary

Measure	Time frame
pH	3.45 hours each study period
Impedance	3.45 hours each study period
Pharmacokinetic variables	3.45 hours each study period

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026