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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00813306

Purpose

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.

Condition	Intervention	Phase
Reflux Episodes	Drug: AZD2066 Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Manometry [ Time Frame: 3.45 hours each study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pH [ Time Frame: 3.45 hours each study period ] [ Designated as safety issue: No ]
Impedance [ Time Frame: 3.45 hours each study period ] [ Designated as safety issue: No ]
Pharmacokinetic variables [ Time Frame: 3.45 hours each study period ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	December 2008
Estimated Study Completion Date:	November 2009

Arms	Assigned Interventions
A: Experimental AZD2066	Drug: AZD2066 13 mg oral solution, 1 single dose
B: Placebo Comparator Placebo	Drug: Placebo Oral solution, 1 single dose
C: Experimental AZD2066	Drug: AZD2066 Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
D: Experimental AZD2066	Drug: AZD2066 Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
E: Placebo Comparator Placebo	Drug: Placebo Oral solution, 1 single dose

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813306

Contacts

Contact: AstraZeneca Clinical Study, Information

800-236-9933

information.center@astrazeneca.com

Locations

Netherlands
Research site	Recruiting
Amsterdam, Netherlands

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Marie Sundin	AstraZeneca R&D Mölndal, Sweden
Principal Investigator:	Guy E Boeckxstaens, MD, PhD	Motiliteitscentrum (C2-310)Department of Gastroenterology,Academic Medical Centre

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Mark Berner-Hansen, MD, PhDMedical Science Director, Early GI )
Study ID Numbers:	D9126C00001
Study First Received:	December 22, 2008
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00813306 History of Changes
Health Authority:	Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by AstraZeneca:

GERD
TLESR
reflux

Study placed in the following topic categories:

Esophageal Disorder
Healthy
Esophageal Diseases

ClinicalTrials.gov processed this record on August 28, 2009