Back to resultsDrug Interaction Study Between AZD3355 and Nexium
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
AZD3355
Esomeprazole
Sponsored by
About this trial
This is an interventional basic science trial for Gastroesophageal Reflux Disease focused on measuring Reflux Inhibitor, GERD, PPI Interaction
Eligibility Criteria
Inclusion Criteria:
- Provision of written informed consent
- Females no childbearing potential
- 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 Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
AZD3355 150 mg
Esomeprazole 40mg
AZD3355 150mg/Esomeprazole 40mg
Outcomes
Primary Outcome Measures
PK variables
Secondary Outcome Measures
4-BOH cholesterol
Safety variables (adverse events, blood pressure, pulse, safety lab)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00684190
Brief Title
Drug Interaction Study Between AZD3355 and Nexium
Official Title
An Open, Randomised, Three Period Cross, Single Centre, Phase 1 Pharmacokinetic Interaction Study of the Reflux Inhibitor AZD3355 150 mg Bid and Esomeprazole 40 mg od After 7 Days of Treatment in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
March 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 evaluate if AZD3355 and Nexium interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.
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, PPI Interaction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AZD3355 150 mg
Arm Title
2
Arm Type
Experimental
Arm Description
Esomeprazole 40mg
Arm Title
3
Arm Type
Experimental
Arm Description
AZD3355 150mg/Esomeprazole 40mg
Intervention Type
Drug
Intervention Name(s)
AZD3355
Other Intervention Name(s)
Lesogaberan
Intervention Description
150 mg bid, oral, 7 days
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
40 mg od, oral, 7 days
Primary Outcome Measure Information:
Title
PK variables
Time Frame
Frequent sampling occasions during day 7 each treatment period
Secondary Outcome Measure Information:
Title
4-BOH cholesterol
Time Frame
Sampling occasions during day 7 one treatment period (AZD3355 alone)
Title
Safety variables (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
Females no childbearing potential
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
Jan Vouis, MD
Organizational Affiliation
Quintiles AB, Uppsala, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
21171670
Citation
Niazi M, Silberg DG, Miller F, Ruth M, Holmberg AA. Evaluation of the pharmacokinetic interaction between lesogaberan (AZD3355) and esomeprazole in healthy subjects. Drugs R D. 2010;10(4):243-51. doi: 10.2165/11588180-000000000-00000.
Results Reference
derived
Learn more about this trial
Drug Interaction Study Between AZD3355 and Nexium
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