Status:
COMPLETED
14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations
Lead Sponsor:
AstraZeneca
Conditions:
Reflux Episodes
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00813306
Start Date
December 1 2008
End Date
November 1 2009
Last Update
December 7 2010
Active Locations (1)
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1
Research site
Amsterdam, Netherlands