Back to resultsStudy to Compare Different Formulations of AZD3355
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
AZD3355
Sponsored by
About this trial
This is an interventional basic science trial for Gastroesophageal Reflux Disease focused on measuring Reflux Inhibitor, GERD, formulations
Eligibility Criteria
Inclusion Criteria:
- Provision of written informed consent
- Female subjects with no childbearing potentials or using highly efficient contraceptive methods
- Clinically normal physical findings
Exclusion Criteria:
- Clinically significant illness within 2 weeks prior to the first dose of investigational product
- History of clinically significant disease
- Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
Arm Description
IR Formulation 65 mg
IR Formulation 150 mg
MR formulation, 1h 65 mg
MR Formulation, 1h 150 mg
MR Formulation, 2h 150 mg
Outcomes
Primary Outcome Measures
Specific AE questions
Secondary Outcome Measures
PK variables
Safety variables (other adverse events, blood pressure, pulse, safety lab)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00688402
Brief Title
Study to Compare Different Formulations of AZD3355
Official Title
A Double-blind, Randomized, Cross-over Design, Phase 1 Pharmacodynamic Study to Investigate the Effect of Different Formulations of AZD3355 for the Development of Paresthesiae After Dosing in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
Reflux Inhibitor, GERD, formulations
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
IR Formulation 65 mg
Arm Title
2
Arm Type
Experimental
Arm Description
IR Formulation 150 mg
Arm Title
3
Arm Type
Experimental
Arm Description
MR formulation, 1h 65 mg
Arm Title
4
Arm Type
Experimental
Arm Description
MR Formulation, 1h 150 mg
Arm Title
5
Arm Type
Experimental
Arm Description
MR Formulation, 2h 150 mg
Intervention Type
Drug
Intervention Name(s)
AZD3355
Other Intervention Name(s)
Lesogaberan
Intervention Description
Single dose
Primary Outcome Measure Information:
Title
Specific AE questions
Time Frame
During 0-4 hours post dose
Secondary Outcome Measure Information:
Title
PK variables
Time Frame
Frequent sampling up to 36 hours post dose
Title
Safety variables (other adverse events, blood pressure, pulse, safety lab)
Time Frame
During the whole treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Provision of written informed consent
Female subjects with no childbearing potentials or using highly efficient contraceptive methods
Clinically normal physical findings
Exclusion Criteria:
Clinically significant illness within 2 weeks prior to the first dose of investigational product
History of clinically significant disease
Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Ersdal, PhD
Organizational Affiliation
AstraZeneca R&D, Mölndal, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aslak Rautio, MD
Organizational Affiliation
Quintiles Hermelinen, Varvsgatan 53, SE-972 33 Luleå, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Varvsgatan
State/Province
Lulea
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Study to Compare Different Formulations of AZD3355
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