NCT00813306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 7, 2010

Status Verified

December 1, 2010

First QC Date

December 22, 2008

Last Update Submit

December 6, 2010

Conditions

Reflux Episodes

Keywords

GERDTLESRreflux

Outcome Measures

Primary Outcomes (1)

  • Manometry

    3.45 hours each study period

Secondary Outcomes (3)

  • pH

    3.45 hours each study period

  • Impedance

    3.45 hours each study period

  • Pharmacokinetic variables

    3.45 hours each study period

Study Arms (5)

A

EXPERIMENTAL

AZD2066

Drug: AZD2066

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

C

EXPERIMENTAL

AZD2066

Drug: AZD2066

D

EXPERIMENTAL

AZD2066

Drug: AZD2066

E

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AZD2066DRUG

13 mg oral solution, 1 single dose

A
PlaceboDRUG

Oral solution, 1 single dose

B

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research site

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

AZD2066

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Marie Sundin

    AstraZeneca R&D, Mölndal, Sweden

    STUDY DIRECTOR

  • Guy E Boeckxstaens, MD, PhD

    Motiliteitscentrum (C2-310)Department of Gastroenterology,Academic Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2008

First Posted

December 23, 2008

Study Start

December 1, 2008

Study Completion

November 1, 2009

Last Updated

December 7, 2010

Record last verified: 2010-12

Locations

NL(1)