14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations
- Registration Number
- NCT00813306
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description D AZD2066 AZD2066 E Placebo Placebo A AZD2066 AZD2066 B Placebo Placebo C AZD2066 AZD2066
- Primary Outcome Measures
Name Time Method Manometry 3.45 hours each study period
- Secondary Outcome Measures
Name Time Method pH 3.45 hours each study period Impedance 3.45 hours each study period Pharmacokinetic variables 3.45 hours each study period
Trial Locations
- Locations (1)
Research site
🇳🇱Amsterdam, Netherlands