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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Reflux Episodes

Intervention / Treatment
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* Drug: AZD2066
* Drug: Placebo
* Drug: AZD2066
* Drug: AZD2066
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AZD2066 | Drug: AZD2066<br>* 13 mg oral solution, 1 single dose<br>|
| Placebo Comparator: B<br>Placebo | Drug: Placebo<br>* Oral solution, 1 single dose<br>|
| Experimental: C<br>AZD2066 | Drug: AZD2066<br>* Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose<br>|
| Experimental: D<br>AZD2066 | Drug: AZD2066<br>* Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose<br>|
| Placebo Comparator: E<br>Placebo | Drug: Placebo<br>* Oral solution, 1 single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manometry |  | 3.45 hours each study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pH |  | 3.45 hours each study period | 
| Impedance |  | 3.45 hours each study period | 
| Pharmacokinetic variables |  | 3.45 hours each study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, TLESR, reflux