Back to resultsAn Interaction Study With Digoxin and AZD1305
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
AZD1305
Digoxin
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, interaction, pharmacokinetic
Eligibility Criteria
Inclusion Criteria:
- A body mass index (BMI=weight/height2) of 19 to 30 kg/m2
Exclusion Criteria:
- Potassium outside normal reference values
- ECG findings outside normal range
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
AZD1305 tablet
AZD1305 tablet + digoxin
Digoxin
Outcomes
Primary Outcome Measures
Pharmacokinetic variables
Secondary Outcome Measures
Adverse event, vital signs, ECG, physical examination and laboratory variables.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00712465
Brief Title
An Interaction Study With Digoxin and AZD1305
Official Title
A Phase I, Randomised, Open, Single-centre, Three-period Crossover Study to Evaluate the Effect of AZD1305 on the Pharmacokinetics of Digoxin After Repeated Oral Administration of AZD1305 and Digoxin to Young Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to learn more about how digoxin is handled by the body, i.e. absorption, distribution, metabolism and excretion, when administered alone and in combination with AZD1305. Secondary purposes are to learn more about how AZD1305 is handled by the body when administered alone and in combination with digoxin and to learn more about how AZD1305 and digoxin administered alone and in combination affect the body.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, interaction, pharmacokinetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AZD1305 tablet
Arm Title
2
Arm Type
Experimental
Arm Description
AZD1305 tablet + digoxin
Arm Title
3
Arm Type
Active Comparator
Arm Description
Digoxin
Intervention Type
Drug
Intervention Name(s)
AZD1305
Intervention Description
Extended Release tablet, repeated administration
Intervention Type
Drug
Intervention Name(s)
Digoxin
Intervention Description
Tablet, repeated administration
Primary Outcome Measure Information:
Title
Pharmacokinetic variables
Time Frame
During all dosing visits
Secondary Outcome Measure Information:
Title
Adverse event, vital signs, ECG, physical examination and laboratory variables.
Time Frame
During the study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A body mass index (BMI=weight/height2) of 19 to 30 kg/m2
Exclusion Criteria:
Potassium outside normal reference values
ECG findings outside normal range
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Lunde, MD
Organizational Affiliation
AstraZeneca R&D, Mölndal, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marianne Hartford, MD, PhD
Organizational Affiliation
AstraZeneca, Clinical Pharmacology Unit, Sahlgrenska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Göteborg
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
An Interaction Study With Digoxin and AZD1305
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