14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations
Study identifier:D9126C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Reflux episodes
Phase
Phase 1/2
Healthy volunteers
Yes
Study drug
AZD2066, Placebo
Sex
All
Actual Enrollment
40
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Dec 2008
Primary Completion Date: -
Study Completion Date: 01 Nov 2009
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| 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 |
Contacts
Investigators
Principal Investigator
Marie Sundin
AstraZeneca R&D Mölndal, Sweden
