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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00813306
First received: December 22, 2008
Last updated: December 6, 2010
Last verified: December 2010
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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:


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: 40
Study Start Date: December 2008
Study Completion Date: November 2009
Arms Assigned Interventions
Experimental: A
AZD2066
Drug: AZD2066
13 mg oral solution, 1 single dose
Placebo Comparator: B
Placebo
Drug: Placebo
Oral solution, 1 single dose
Experimental: C
AZD2066
Drug: AZD2066
Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
Experimental: D
AZD2066
Drug: AZD2066
Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
Placebo Comparator: E
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
Research site
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: Mark Berner-Hansen, MD, PhDMedical Science Director, Early GI, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00813306     History of Changes
Other Study ID Numbers: D9126C00001
Study First Received: December 22, 2008
Last Updated: December 6, 2010
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by AstraZeneca:
GERD
TLESR
reflux

ClinicalTrials.gov processed this record on September 18, 2014