An Interaction Study With Digoxin and AZD1305

Phase 1

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: AZD1305; Drug: Digoxin

• Registration Number: NCT00712465
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-09
• Study First Posted: 2008-07-10
• Study Start: 2008-08
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD1305	AZD1305 tablet
2	AZD1305	AZD1305 tablet + digoxin
2	Digoxin	AZD1305 tablet + digoxin
3	Digoxin	Digoxin

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic variables	During all dosing visits

Secondary Outcome Measures

Name	Time	Method
Adverse event, vital signs, ECG, physical examination and laboratory variables.	During the study

Trial Locations

Locations (1)

Research Site; 🇸🇪 Göteborg, Sweden